Governments
! This page contains references to documents produced by governments of all countries or international bodies. For this reason, it may be too general to do a useful search !
And it takes long to charge ...
| Title | Link |
|---|---|
| OECD - Conference on New Biotechnology Food and Crops, Science, Safety and Society - Bangkok, Thailand, July 10-12, 2001.- (29 pages) | http://www1.oecd.org/bangkok/bangkokfinalreport.PDF |
| OECD - Report of the OECD workshop on the toxicological and nutritional testing of novel foods -Meeting of the Ad Hoc Expert Group on Food Safety - (48 pages) | http://www1.oecd.org/ehs/ehsmono/aussoidrEN.pdf |
| OECD - Safety Assessments of new foods - results of an OECD Survey of Serum Banks for Allergenicity testing, and use of databases - Internal co-ordination group for biotechnology - February 1997 - (34 pages) | http://www1.oecd.org/ehs/ehsmono/surveydrEN.pdf |
| OECD - Carliene Brenner - Intellectual property rights and technology transfer in developing country agriculture: rhetoric and reality - Technical paper 133 - March 1998 - (51 pages) | http://www1.oecd.org/dev/PUBLICATION/tp/Tp133.pdf |
| FDA - CDER - subscribe to mailing lists free of charge. | http://www.fda.gov/cder/cdernew/listserv.html |
| FDA -(proposed) Pediatric Rule - Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients - 21 CFR Parts 201, 312, 314, and 601 - (99 pages) | http://www.fda.gov/cder/guidance/pedrule.pdf |
| US. District Court for the District of Columbia - Memorandum and opinion -October 25, 2001 - (24 pages) | http://www.cei.org/pdfs/pediatric-ruling.pdf |
| U.S. Department of Health and Human Services - Pediatric Advisory Subommittee Ethical Issues Day 1 - November 15, 1999 - (291 pages) | http://www.medicigroup.com/resources/Resources-Ethics%20&%20Patient%20Recruitment.pdf |
| Swissmedic Journal 1/2002 (32 pages) | http://www.swissmedic.ch/files/pdf/01_2002.pdf |
| Swissmedic - home page (english) | http://www.swissmedic.ch/?lang=2 |
| Commission Regulation (EC) No 240/96 of 31 January 1996 on the application of Article 85 (3) of the Treaty to certain categories of technology transfer agreements | http://europa.eu.int/eur-lex/en/lif/dat/1996/en_396R0240.html |
| Commission
evaluation report on the transfer of technology block exemption
regulation n° 240/96 (44 pages) Technology transfer agreements under article 81 |
http://www.europa.eu.int/comm/competition/antitrust/technology_transfer/en.pdf |
| Federal Council - Message relatif à la révision de la loi sur les cartels - | http://www.evd.admin.ch/dynamic/dm/LOI_SUR_LES_CARTELS/F/MESSAGE/Message_relatif_a_la_revision_de_la_loi_sur_les%20cartels.pdf |
| Importations parallèles et droit des brevets Rapport du Conseil fédéral du 8 mai 2000 en réponse à la question de la Commission de l'économie et des redevances du Conseil national (CER) du 24 janvier 2000 - (from page 38) | http://www.evd.admin.ch/dynamic/dm/LOI_SUR_LES_CARTELS/F/MESSAGE/Message_relatif_a_la_revision_de_la_loi_sur_les%20cartels.pdf |
| J.C. Dumon, M. Sneyers et W. Moens - Report: First Gene Therapy Related Death - Belgian Biosafety Council - 2000 - (20 pages) | http://biosafety.ihe.be/GT/regulatory/RapportEN27_06_2001.pdf |
| Gene Therapy Advisory Committee - Health Departments of the United Kingdom - 1999 - (58 pages) | http://www.doh.gov.uk/genetics/gtac6.pdf |
| FDA - Warning Letter of March 3, 2000 to the University of Pennsylvania in relation with the death of Jesse Gelsinger during a clinical trial | http://www.fda.gov/foi/warning_letters/m3435n.pdf |
| USPTO - Patenting By Geographic Region (State and Country), Breakout by Technology Class Count of 1996 - 2000 Utility Patent Grants By Calendar Year of Grant | http://www.uspto.gov/web/offices/ac/ido/oeip/taf/clsstc/regions.htm |
| Institute of Medicine - Small Clinical Trials: issues and challenges - 2001 | http://books.nap.edu/books/0309073332/html/R1.html#pagetop |
| Keith E. Maskus - Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing Countries - Final Report to WIPO - April 2001 - (85 pages) | http://www.wipo.int/about-ip/en/studies/pdf/ssa_maskus_pi.pdf |
| Christopher Heath - Parallel Imports and International Trade - WIPO - (12 pages) | http://www.wipo.org/sme/en/documents/pdf/atrip_gva_99_6.pdf |
| Parallel Importing A Theoretical and Empirical Investigation - Report to Ministry of Commerce - Prepared by NZIER - February 1998 | http://www.med.govt.nz/buslt/int_prop/parallel/index.html#TopOfPage |
| K Balasubramaniam - Equitable Pricing, Affordability and Access to Essential Drugs in Developing Countries: Consumers Perspective - WTO - (12 pages) | http://www.wto.org/english/tratop_e/trips_e/hosbjor_presentations_e/35balasubramaniam_e.pdf |
| Conseil national - Motion CSEC-CN (00.455). Autorisation du diagnostic préimplantatoire lors de risque grave - March 20, 2002 | http://www.parlament.ch/ab/frameset/f/n/4612/55916/f_n_4612_55916_55939.htm |
| WHO - Lignes Directrices Opérationnelles pour les Comités d’Ethique chargés de l’évaluation de la Recherche Biomédicale - 2000 - (19 pages) | http://www.who.int/tdr/publications/publications/pdf/ethicsfr.pdf |
| Critique internationale des essais suisses de prescription d’héroïne Rapport de la Commission externe d’experts de l’OMS Prises de position de l’Organe international de contrôle des stupéfiants (OICS) - (53 pages) | http://www.aegd.ch/pdf/kritik_franz.PDF |
| Swiss Ethics Committee on Non-human Gene Technology Avis relatif au projet de loi fédérale sur la transplantation d'organes, de tissus et de cellules (loi sur la transplantation, LTx) mis en consultation - (11 pages) | http://www.buwal.ch/stobobio/ekah/pdf/280200f.pdf |
| Helsinki Declaration - World Medical Association - Ethical Principles for Medical Research Involving Human Subjects - last amendment 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 - (5 pages) | http://www.wma.net/e/policy/17c.pdf |
| Title 21--Food and Drugs Chapter I - - Part 50--Protection of Human Subjects | http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html |
| Title 21--Food and Drugs Chapter I-- Part 56--Institutional Review Boards | http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html |
| The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research - April 18, 1979 | http://ohsr.od.nih.gov/mpa/belmont.php3 |
| US - Title 45 CFR Part 46 - Protection Of Human Subjects | http://ohsr.od.nih.gov/mpa/45cfr46.php3 |
| Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health | http://ohsr.od.nih.gov/guidelines.php3 |
| IRB Protocol Review Standards - Minimal regulatory requirements for IRB review, discussion and documentation in the meeting minutes | http://ohsr.od.nih.gov/info/checklist_IRB_protocol.html |
| IRB - OHSR Information Sheets | http://ohsr.od.nih.gov/info/ |
| Address by Joel I. Klein - Cross-Licensing and Antitrust Law -Before the American Intellectual Property Law Association - San Antonio Marriott Rivercenter San Antonio, Texas - May 2, 1997 | http://www.apeccp.org.tw/doc/USA/Policy/speech/1123.htm |
| WTO - Ministerial Declaration - Adopted on 14 November 2001 - (10 pages) | http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_e.pdf |
| WTO -Declaration on the TRIPS Agreement and Public Health - Adopted on 14 November 2001 - (2 pages) | http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf |
| WTO - Implementation-Related Issues and Concerns - Decision of 14 November 2001 - (8 pages) | http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_implementation_e.pdf |
| FTC - In the Matter of 180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications - Comment of the Staff of the Bureau of Competition and of Policy Planning of the FTC - November 4, 1999 | http://www.ftc.gov/be/v990016.htm |
| Swissmedic - Formulaire de base pour la soumission d'un projet de recherche biomédicale | http://www.swissmedic.ch/files/pdf/f_FormEKAntrag.doc |
| Swissmedic - Formulaire d'avis de la Commission d'éthique de la recherche | http://www.swissmedic.ch/files/pdf/f_FormEKBeschluss.doc |
| Swissmedic - Formulaire de notification pour les essais cliniques de médicaments | http://www.swissmedic.ch/files/pdf/B3.1.121_Formulair_de_notification_pour_les_essais_cliniques_de_m%E9dicaments.dot |
| Swissmedic - list of ethics committee | http://www.swissmedic.ch/files/pdf/Liste_Ethikkommissionen-f.pdf |
| Swissmedic - Commentaires concernant le formulaire «Demande d’autorisation / modification» | http://www.swissmedic.ch/files/pdf/Commentaires%20sur%20le%20formulaire%20demande%20d%27autorisation%20-%20modification.pdf |
| OClin - Federal Ordinance on clinical trials | http://www.admin.ch/ch/f/rs/8/812.214.2.fr.pdf |
| Préposé fédéral à la protection des données - Guide relatif au traitement de données personnelles dans le domaine médical - (53 pages) | http://www.edsb.ch/f/doku/leitfaeden/medizin.pdf |
| Conseil de l'Europe Comité des Ministres Recommandation No R(90)3 du Comité des Ministres aux Etats membres sur la recherche médicale sur l'être humain adoptée par le Comité des Ministres le 6 février 1990 | http://www.inserm.fr/ethique/Ethique.nsf/397fe8563d75f39bc12563f60028ec43/325e8f4b601fa154c125675400383408?OpenDocument |
| COMITE
DIRECTEUR POUR LA BIOETHIQUE (CDBI) - Développement dans le domaine de
la bioéthique dans les Etats membres, dans les autres Etats et dans les organisations internationales - Strasbourg, le 26 Octobre 2001 - (83 pages) |
http://www.legal.coe.int/bioethics/pdf/CDBI-INF(2001)6F.pdf |
| The Danish Council of Ehtics - Genetic investigation of Healthy Subjects - Report on Presymptomatic Gene Diagnosis | http://www.etiskraad.dk/publikationer/genetic/ren.htm |
| HGC and the Human Fertilisation Embryology Authority (HFEA) - Outcome of the Public Consultation on Preimplantation Genetic Diagnosis - (33 pages) | http://www.hgc.gov.uk/business_publications_pgdoutcome.pdf |
| Human Genetics Commission - First Annual Report- (58 pages) | http://www.hgc.gov.uk/business_publications_annualreport_first.pdf |
| CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects - Revised draft, January 2002 | http://www.cioms.ch/frame_guidelines_january_2002.htm |
| CIOMS - The Declaration of Inuyama - Human Genome Mapping, Genetic Screening and Gene Therapy | http://www.cioms.ch/frame_1990_texts_of_guidelines.htm |
| CIOMS - International Guiding Principles for Biomedical Research Involving Animals (1985) | http://www.cioms.ch/frame_1985_texts_of_guidelines.htm |
| EU - Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.efgcp.org/webdocs/guidelines_for_retention.pdf |
| US - 106TH Congress 1ST Session H. R. 626 - "Health Care Research and Development and Taxpayer Protection Act’’ | http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=106_cong_bills&docid=f:h626ih.txt.pdf |
| WHO WTO - Report of the Workship on differential pricing and financing of essential Drug - April 2001 - (27 pages) | http://www.who.int/medicines/library/edm_general/who-wto-hosbjor/wholereporthosbjorworkshop-fin-eng.pdf |
| S. Jacobzone - Pharmaceutical Policies on OECD Countries : Reconciling Social and Industrial Goals - Labour Market and Social Policy - Occasional Papers No. 40 - (100 pages) | http://www.olis.oecd.org/OLIS/2000DOC.NSF/c5ce8ffa41835d64c125685d005300b0/c125685b0057c558c12568c400331a1e/$FILE/00075948.PDF |
| Federal Department of Justice - Explications relatives à l'ordonnance sur la procréation médicalement assistée - (6 pages) | http://www.ofj.admin.ch/themen/fortpflmed/vnvo-ber-fmedv-f.pdf |
| Federal Department of Justice - Explications relatives à l'ordonnance sur la Commission nationale d'éthique dans le domaine de la médecine humaine - (4 pages) | http://www.ofj.admin.ch/themen/fortpflmed/vnvo-ber-vnek-f.pdf |
| Loi fédérale sur la protection des données (LPD) du 19 juin 1992 -RS 235.1 - (16 pages) | http://www.admin.ch/ch/f/rs/2/235.1.fr.pdf |
| Proposed changes to the Federal Law on Data Protection (LPD) - (19 pages) | http://www.ofj.admin.ch/themen/datenschutz/bg-revision-f.pdf |
| Avant-projet et rapport explicatif relatif à la révision de la loi fédérale sur la protection des données; Protocole additionnel à la Convention pour la protection des personnes à l'égard du traitement automatisé des données à caractère personnel | http://www.ofj.admin.ch/themen/datenschutz/vn-ber-f.pdf |
| United Kingdom - Advice to Research Ethics Committees - Points to consider in ethical review of medical research involving genetic testing - October 1998 - (13 pages) | http://www.doh.gov.uk/pub/docs/doh/recrev3.pdf |
| FDA - Guidance for Industry - Content and format of investigational new drug applications (inds) for phase 1 studies of drugs, including wellcharacterized, therapeutic, biotechnology-derived products - (18 pages) | http://www.fda.gov/cder/guidance/phase1.pdf |
| FDA - Guidelines for Drug Master Files - September 1989 | http://www.fda.gov/cder/guidance/dmf.htm |
| Federal Food, Drug and Cosmetic Act - Portions revised or new- As Amended by the FDA Modernization Act of 1997 | http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm |
| ICH - Guidance for Industry E 10 Choice of Control Group and Related Issues in Clinical Trials - May 2001 - (37 pages) | http://www.fda.gov/cder/guidance/4155fnl.pdf |
| FDA
- Guidance for Industry Acceptance of Foreign Clinical Studies -March 2001 - (4 pages) |
http://www.fda.gov/cder/guidance/fstud.pdf |
| FDA - Information Sheets - Guidance for Institutional Review Boards and Clinical Investigators- IRB Operations and Clinical Investigation Requirements - 1998 Update | http://www.fda.gov/oc/ohrt/irbs/default.htm |
| EMEA - Fees payable to the EMEA - Human Medicinal Products | http://www.emea.eu.int/htms/general/admin/fees/feesh.htm http://www.emea.eu.int/pdfs/general/direct/fees/711499en.pdf |
| EMEA - EMEA/17424/01 Position Statement on the Use of Placebo in Clinical Trials with regard to the Revised Declaration of Helsinki - June 2001 | http://www.emea.eu.int/pdfs/human/press/pos/1742401en.pdf |
| EMEA - Market Authorisation Withdrawals (Also includes Suspensions of MA) | http://www.emea.eu.int/htms/human/withdraw/withdraw.htm |
| EMEA - EMEA/H/30313/98 Revision 1 Procedure for Notifications of Parallel Distribution of Centrally Authorised Medicinal Products - (page 4) | http://www.emea.eu.int/pdfs/human/parallel/3031398en.pdf |
| EMEA - CPMP Opinions on approval or refusal of marketing authorizations | http://www.emea.eu.int/htms/human/opinion/opinion.htm |
| EMEA - CPMP/EWP/462/95 Note for Guidance on Clinical Investigation of Medicinal Products in Children (CPMP adopted March 97) - (12 pages) | http://www.emea.eu.int/pdfs/human/ewp/046295en.pdf |
| EMEA - CPMP/EWP/240/95 Note for Guidance on Fixed Combination Medicinal Products (CPMP adopted April. 96) - (5 pages) | http://www.emea.eu.int/pdfs/human/ewp/024095en.pdf |
| U.S. - EC MRA (Mutual Recognition Agreement) Pharmaceutical Good Manufacturing Practices Annex - Sectoral Annex for Pharmaceutical Good Manufacturing Practices GMPs) - (29 pages) | http://pharmacos.eudra.org/F2/mra/doc/mraecus.pdf |
| U.S. - EC MRA - Joint Procedure for the Information Exchange of Serious or Life-Threatening Human / Animal Pharmaceutical Product Quality Defects and Recalls - (7 pages) | http://www.emea.eu.int/pdfs/technical/mra/usa/008600en.pdf |
| FDA - Compliance Program Guidance Manual For FDA Staff - Compliance Program 7348.811 - Bioresearch Monitoring: Clinical Investigators | http://www.fda.gov/ora/compliance_ref/bimo/7348_811/default.htm |
| FDA - Compliance Program 7348.810 - Bioresearch Monitoring Sponsors, Contract Research Organizations and Monitors - Date of Issuance: February 21, 2001 - Guidance for FDA Staff | http://www.fda.gov/ora/compliance_ref/bimo/7348_810/default.htm |
| FDA - Good Laboratory Practice - GLP Final Rule - (81 pages) | http://www.fda.gov/ora/compliance_ref/bimo/GLP/78fr-glpfinalrule.pdf |
| WHO - WHO Technical Report Series, No. 850, 1995, Annex 3 - Guidelines for good clinical practice (GCP) for trials on pharmaceutical products - (35 pages) | http://www.who.int/medicines/library/par/ggcp/GCPGuidePharmatrials.pdf |
| WHO - General Guidelines for Methodologies on Research and Evaluation of Traditional Medicine - (80 pages) | http://www.who.int/medicines/library/trm/who-edm-trm-2000-1/who-edm-trm-2000-1.pdf |
| WHO - Criteria for Medicinal Drug Promotion - (8 pages) | http://www.who.int/medicines/library/dap/ethical-criteria/criteriamedicinal.pdf |
| WHO, MSF and others - Sources and prices of selected drugs and diagnostics for people living with HIV/AIDS. May 2001 - (38 pages) | http://www.who.int/medicines/library/par/hivrelateddocs/sourcesandprices31may01.pdf |
| WHO and UNAIDS - Patent situation of HIV/AIDS-related drugs in 80 countries - Geneva, January 2000 - (16 pages) | http://www.who.int/medicines/library/par/hivrelateddocs/patentshivdrugs.pdf |
| Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1993/en_393L0042.html |
| Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0385.html |
| Swissmedic - form - requête d'autorisation d'exploitation - (fabrication, importation, exportation, commerce, etc.) - (3 pages) | http://www.swissmedic.ch/files/pdf/B3.3.12-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploitation - annexe A - Fabrication de médicaments (manufacture of drugs) - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.3.13-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe B - Importation de médicaments (prêts à l'emploi) (drug imports) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.14-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe C - Commerce de gros de médicaments (drug wholesaler authorization) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.15-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe D - Exportation de médicaments (prêts à l'emploi) (ready-made drug exports) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.16-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe E - Commerce à l'étranger de médicaments (sale of drugs in foreign countries) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.17-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe F - Prélèvement de sang pour la transfusion ou la fabrication de médicaments (blood taking for transfusion / drug manufacturing) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.17-f.pdf |
| Swissmedic - form - demande d'autorisation / modification - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.11-f.pdf |
| Swissmedic - form - announce d'effets indésirables suspectés d'un médicament (EI) (possible drug adverse event) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.2.16_Formulaire_d%27annoce_EI.pdf |
| Swissmedic - form - demande d'octroi d'une autorisation Swissmedic pour médicament à l'expiration de l'enregistrement OICM - (change from IOCM to Swissmedic authorization) (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.96_demande_d%27octroi_%E0_l%27%E9ch%E9ance_d%27enregistrement_OICM-usage_humain.dot |
| Swissmedic - form - statut des demandes d'autorisation déposées à l'étranger | http://www.swissmedic.ch/files/pdf/B3.1.92%20demandes%20d%27autorisation%20d%E9pos%E9e%20%E0%20l%27%E9tranger.doc |
| Swissmedic - form - produit d'origine animale présentant un risque d'EST - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.91-f.pdf |
| Swissmedic - form - renseignements concernant les fabricants - (6 pages) | http://www.swissmedic.ch/files/pdf/B3.1.28-f.pdf |
| Swissmedic - list of countries from which imports of drugs in Switzerland are possible (following a simplified procedure) | http://www.swissmedic.ch/overall.asp?theme=0.00107&theme_id=362&nm4prm=cGFnZT0xJmlkPTE5NjM= |
| NIH - Public Health Service Policy relating to Distribution of Unique Research Result Resources produced with PHS Funding - NIH Guide , Volume 25, Number 23, July 12, 1996 | http://grants1.nih.gov/grants/guide/notice-files/not96-184.html |
| NIH -Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources: Final Notice | http://ott.od.nih.gov/NewPages/RTguide_final.html#guide |
| NIH - Implementation Issues for Human Embryonic Stem Cell Research - Frequently Asked Questions | http://grants1.nih.gov/grants/stem_cell_faqs_topic.htm |
| NIH - Human Embryonic Stem cell registry | http://escr.nih.gov/ |
| NIH - Notice of criteria for federal funding of research on existing human embryonic stem cells and establishment of NIH human embryonic stem cell registry | http://grants1.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html |
| WIPO (monthly) magazine 2002 (access to pdf files) | http://www.wipo.org/publications/general/121/2002/index.html |
| Résultats de la procédure de consultation sur la Convention internationale sur les droits de l'homme et la biomédecine - 6 pages) | http://www.ofj.admin.ch/themen/bioeth/ve-ber-f.pdf |
| Rapport en vue de la procédure de consultation sur la Convention internationale sur la biomédecine - Septembre 1998 - (42 pages) | http://www.ofj.admin.ch/themen/bioeth/vn-ber-f.pdf |
| WHO - Application for Inclusion of didanosine on WHO Model List of Essential Medicines | http://www.who.int/medicines/organization/par/edl/didanosine.doc |
| WHO - Legal Status of Traditional Medicine and Complementary/Alternative Medicine: A Worldwide Review - (199 pages) | http://www.who.int/medicines/library/trm/who-edm-trm-2001-2/LegalStatus-final.pdf |
| USTR - Report on Switzerland's barriers to trade - (4 pages) + foreword | http://www.ustr.gov/reports/nte/2002/switzerland.PDF http://www.ustr.gov/reports/nte/2002/foreword.PDF |
| Health Care Inspectorate of the Netherlands - Marketing plans for medicinal products available on prescription only: the current situation - The Hague, July 2001, second revised edition | http://www.healthyskepticism.org/editions/2002/IN04.htm |
| Swiss Expert Committee for Biosafety (EFBS/CFSB) - English home page - "the permanent federal advisory Committee on questions relating to the protection of people and the environment in the areas of gene- and biotechnology" | http://www.buwal.ch/stobobio/cfsb/e/index.htm |
| ILO - International Labour Organization - An ILO code of practice on HIV/AIDS and the world of work - 2001 - (38 pages) | http://www.ilo.org/public/english/protection/trav/aids/download/pdf/hiv_a4_e.pdf |
| Arrêté fribourgeois du 12 septembre 1995 concernant les essais cliniques sur l’être humain | http://www.fr.ch/v_ofl_bdlf/en_vigueur/fra/8212022v0001.doc |
| Communication concernant l'appréciation des accords verticaux - Décision de la Commission de la concurrence du 18 février 2002 | http://www.wettbewerbskommission.ch/site/f/medien/Medienmitteilungen.Par.0027.Pic2.pdf |
| FDA - Office of Medical Policy - Division of Drug Marketing, Advertising, and Communications - Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs Main Survey Results | http://www.fda.gov/cder/ddmac/dtcindex.htm http://www.fda.gov/cder/ddmac/dtcfllw.htm |
| FDA - Division of Drug Marketing, Advertising, and Communications National Surveys of Prescription Medicine Information Received by Consumers | http://www.fda.gov/cder/ddmac/Y2KTITLE.HTM |
| FDA - Evaluation of Written Prescription Information Provided in Community Pharmacies: An 8-State Study | http://www.fda.gov/cder/calendar/meeting/rx2000/report1.htm |
| FDA - Center for Drug Evaluation and Research - Transcript of a Public Meeting: Current Status of useful written Prescription Drug Information for Patients, Volumes I and II - February 29, 2000 | http://www.fda.gov/cder/ddmac/tranvol1.htm http://www.fda.gov/cder/ddmac/tranvol2.htm |
| FDA - Guidance for Industry Consumer-Directed Broadcast Advertisements - (6 pages) | http://www.fda.gov/cder/guidance/1804fnl.pdf |
| FDA - Guidance for Industry - Industry-Supported Scientific and Educational Activities | http://www.fda.gov/cder/guidance/isse.pdf |
| FDA - Guidance for Industry - Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling - Draft Guidance - (8 pages) | http://www.fda.gov/cder/guidance/1955dft.pdf |
| FDA - Draft Guidance for Industry - Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) - (6 pages) | http://www.fda.gov/cder/guidance/1726dft.pdf |
| FDA - Guidance for Industry Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements - (7 pages) | http://www.fda.gov/cder/guidance/4114dft.pdf |
| Patent Law Statute - 35 U.S.C. - (68 pages) | http://www.law.duke.edu/curriculum/courseHomepages/spring2002/369_01/patentstatute.pdf |
| Merck v. Kessler, 903 F. Supp. 964, (E.D.Va. 1983) | http://www.law.berkeley.edu/institutes/bclt/courses/fall99/merck.html |
| Roche v. Bolar, 572 F. Supp. 255 (E.D.N.Y. 1983) | http://www.law.berkeley.edu/institutes/bclt/courses/fall99/roche.html |
| Eli Lilly v. Medtronic, 15 U.S.P.Q.2.d 1121 (S. Ct. 1990) | http://www.law.berkeley.edu/institutes/bclt/courses/fall99/lilly.html |
| Amgen v. Hoechst Marion Roussel and Transkaryotic Therapies, 3 F. Supp.2d 104 (D. Mass. 1998) | http://www.law.berkeley.edu/institutes/bclt/courses/fall99/amgen.html |
| Berlex Laboratories v. Food and Drug Administration, 942 F. Supp. 19 (D.D.C. 1996) | http://www.law.berkeley.edu/institutes/bclt/courses/fall99/berlex.html |
| FDA - Guidance List - (31 pages) | http://www.fda.gov/cder/guidance/guidlist.pdf |
| ICH - Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH M2 EWG Electronic Common Technical Document Specification - 2002 - (160 pages) | http://www.fda.gov/cder/m2/eCTD%20Step%202/eCTD%20Specification%20v2-0-1.pdf |
| FDA - Electronic Common Technical Document FDA Regional Information - (14 pages) | http://www.fda.gov/cder/regulatory/ersr/FDARegional/FDA_regional_eCTD/FDA%20Regional%20-%20Instructions.doc |
| FDA - Use of Placebo controls in developing countries - (13 pages) | http://www.citizen.org/documents/1558attachment.pdf |
| AAC Consulting Group - Audit of Schering-Plough Manufacturing Facility - 2000, (15 pages) | http://www.citizen.org/documents/schering200.pdf |
| White House Commission on Complementary and Alternative Medicine Policy - Final Report -March 2002 | http://www.whccamp.hhs.gov/finalreport.html |
| C-318/90 Case decision of June 3, 1992 Hauptzollamt Mannheim / Boehringer Rec.1992,p.I-3495) | http://www.curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| C-285/91 - Judgment of 18/02/1993, Merck / Hauptzollamt Hamburg-Jonas (Rec.1993,p.I-729 | http://www.curia.eu.int/common/recdoc/indexaz/en/c2.htm#C-427/93 |
| High Level Group Set to Improve Equality of Access to New Medicines Across EU NEWS RELEASE Innovative Medicines and the EU Citizen – Swedish Session - (3 pages) | http://dg3.eudra.org/F3/g10/docs/g10w_250102_2.pdf |
| FTC - Analysis to Aid Public Comment and Complaint and Agreement of FTC case against Biovail Corporation | http://www.ftc.gov/os/2002/04/biovailanalysis.htm http://www.ftc.gov/os/2002/04/biovaildecision.htm http://www.ftc.gov/os/2002/04/biovailcomplaint.htm |
| Combating Deception in Dietary Supplement Advertising Remarks By Commissioner Sheila F. Anthony Before The Food and Drug Law Institute 45th Annual Educational Conference - Washington, DC - April 16, 2002 | http://www.ftc.gov/speeches/anthony/dssp2.htm |
| FTC - Analysis of proposed consent order to aid public comment - In the Matter of Interstate Bakeries Corporation, File No. 012 3182 | http://www.ftc.gov/os/2002/03/interstateana.htm |
| FTC - Analysis to Aid Public Comment - AHP unlawfully agreed with Schering-Plough Corporation to delay selling its generic version of Schering's K-Dur 20, | http://www.ftc.gov/os/2002/02/ahpanalysis.htm |
| FTC - FTC Staff Opposes Alaska Proposal to Allow Physician Collective Bargaining - Proposed Legislation Would Significantly Increase Consumer Health Care Costs - January 2002 | http://www.ftc.gov/opa/2002/01/alaskaphysicians.htm |
| FTC - Eli Lilly Settles FTC Charges Concerning Security Breach Company Disclosed E-mail Addresses of 669 Subscribers to its Prozac Reminder Service - January 2002 | http://www.ftc.gov/opa/2002/01/elililly.htm |
| WHO - Draft Scaling Up Antiretroviral Therapy in Resource Limited Settings : Guidelines for a Public Health Approach - 2002 - (115 pages) | http://www.who.int/HIV_AIDS/HIV_AIDS_Care/ARV_Draft_April_2002.pdf |
| Swissmedic - Evolution du nombre de prescriptions de RITALINE® (méthylphénidate) dans le canton de Neuchâtel entre 1996 et 2000 - (13 pages) | http://www.newsmaker.ch/upload/customers/swissmedic/Enquête_Ritaline_Neuchâtel.pdf |
| Swissmedic - Commerce de médicaments par Internet -Rapport du groupe de travail « commerce électronique » à l’intention du directeur de l’OICM - (17 pages) | http://www.swissmedic.ch/files/pdf/Rapport_e-commerce.pdf |
| FY 2001 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 | http://www.fda.gov/oc/pdufa/report2001/pdufareport.html |
| C-427/93, C-429/93 and C-436/93 - Judgment of the Court of 11 July 1996. Bristol-Myers Squibb v Paranova A/S and C. H. Boehringer - Repackaging of trade-marked products. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Proposed Bill by Senator Dorgan - To permit commercial importation of prescription drugs from Canada, and for other purposes. | http://dorgan.senate.gov/meds.pdf |
| Rapport de la Commission de gestion du Conseil des Etats - Influence de la Confédération sur la maîtrise des coûts dans le domaine de la loi sur l’assurance-maladie – Analyse de deux exemples précis - 5 avril 2002 - (22 pages) | http://www.parlament.ch/F/Veroeffentlichungen/Kommissionsberichte/KVG_GPK_S_f.pdf |
| Initiative parlementaire Indemnisation des victimes stérilisées de force - Avant-projet et rapport explicatif de la Commission des affaires juridiques du Conseil national du 6 novembre 2001 - (32 pages) | http://www.ejpd.admin.ch/doks/mm/2002/020327b_entw-f.pdf |
| Mesures de maîtrise des coûts dans la LAMal - Mesures et marge de manœuvre des organes responsables de la Confédération Synthèse à l’attention de la Commission de gestion du Conseil des États - November 30, 2001 - (35 pages) | http://www.parlament.ch/F/Veroeffentlichungen/Kommissionsberichte/KVGSynthese_PVK_f.pdf |
| US Trade Representative (USTR) - 2002 Special 301 Report Executive Summary - (35 pages) | http://www.ustr.gov/reports/2002/special301-report.PDF |
| USTR Information on NAFTA | http://www.ustr.gov/regions/whemisphere/nafta.shtml |
| Institute of Medicine - The Development of Medications for the Treatment of Opiate and Cocaine Addictions: Issues for the Government and Private Sector (1995) | http://books.nap.edu/books/0309052440/html/1.html |
| U.S. Department of Health and Human Services' - Conference on Pharmaceutical Pricing Practices, Utilization, and Costs August 8th & 9th | http://aspe.hhs.gov/health/reports/Drug-papers/index.htm |
| The Pediatric Exclusivity Provision - January 2001- Status Report to Congress - (57 pages) | http://www.fda.gov/cder/pediatric/reportcong01.pdf |
| Pharmaceutical Industry Competitiveness Task Force - Final Report – March 2001 - (95 pages) | http://www.doh.gov.uk/pictf/pictf.pdf |
| Institute of Medicine Rational Therapeutics for Infants and Children - Workshop Summary | http://search.nap.edu/html/rational_therapeutics/ |
| Recent Developments and Challenges in the Protection of intellectual property rights pharmaceuticals and biotechnological Inventions - May 2001 - (24 pages) | http://www.wipo.org/ip-conf-bg/en/documents/pdf/sof01_2_5.pdf |
| U.S. Supreme Court decision - Thompson v. Western States Medical Center - No.01-344. Argued February 26, 2002 -- Decided April 29, 2002 - (19 pages) - free speech | http://supct.law.cornell.edu/supct/pdf/01-344P.ZO http://supct.law.cornell.edu/supct/pdf/01-344P.ZC http://supct.law.cornell.edu/supct/pdf/01-344P.ZD |
| U.S. Supreme Court decision - Warner Jenkinson Co., Inc. v. Hilton Davis Chemical Co. (95-728), 520 U.S. 17 (1997). - patent law | http://supct.law.cornell.edu/supct/html/95-728.ZO.html |
| U.S. Supreme Court decision - FDA v. Brown & Williamson Tobacco Corp. (98-1152) 153 F.3d 155, affirmed. (39 pages & 32 pages) - tobacco as a drug/device | http://supct.law.cornell.edu/supct/pdf/98-1152P.ZO http://supct.law.cornell.edu/supct/pdf/98-1152P.ZD |
| U.S. Supreme Court decision - BRAGDON v. ABBOTT (97-156) 107 F.3d 934, vacated and remanded. - (29 pages) - AIDS disability | http://supct.law.cornell.edu/supct/pdf/98-1152P.ZD |
| U.S. Supreme Court decision - Madsen v. Women's Health Ctr. (93-880), 512 U.S. 753 (1994). - abortion and free speech | http://supct.law.cornell.edu/supct/html/93-880.ZO.html |
| Judgment of 23/04/2002, Merck, Sharp & Dohme - Case C-443/99.- Exhaustion of the rights conferred by the trade mark | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of 23/04/2002, Boehringer Ingelheim and others - C-143/00 - Exhaustion of the rights conferred by the trade mark | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Pharmaceuticals in the European Union - booklet - (31 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/brochurenov99.pdf |
| FDA Backgrounder - FDA's Budget Request for FY 2002 | http://www.fda.gov/opacom/backgrounders/budget.html |
| FDA - Milestones in U.S. Food and Drug Law History | http://www.fda.gov/opacom/backgrounders/miles.html |
| FDA- FY 2002 Congressional Budget Request - Various documents | http://www.fda.gov/oc/oms/ofm/budget/2002/2002budget.htm |
| JAAC 59.34 -Décision de la Commission fédérale de recours en matière de douanes du 27 octobre 1994 - Capsules Y | http://www.vpb.admin.ch/franz/doc/59/59.34.html |
| Swiss Federal Institute of Intellectual Property - Patents - Directives pour l'examen quant au fond - (156 pages) | http://www.ige.ch/F/jurinfo/pdf/dirpat.pdf |
| ATF 96 I 752 - Arrêt du TF sur la marque Enterocura | http://wwwsrv1.bger.ch/atf/index/96_I.html |
| U.S. DOJ - Health Care Business Review Letters Inssued (Since 1993 Issuance of DOJ/FTC Health Care Antitrust Statements of Enforcement Policy: Current as of 1/27/97) | http://www.usdoj.gov/atr/public/busreview/1032.htm |
| Richard G. Parker & David A. Balto - The Evolving Approach to Merger Remedies [published in Antitrust Report (May 2000)] | http://www.ftc.gov/speeches/other/remedies.htm |
| Speech of Mary L. Azcuenaga - The Intersection of Antitrust and Intellectual Property: Adaptations, Aphorisms and Advancing the Debate | http://www.ftc.gov/speeches/azcuenaga/alis.htm |
| U.S. DOJ - Antitrust Division Health Care Task Force - Recent Enforcement Actions | http://www.usdoj.gov/atr/public/health_care/2044.htm |
| United States Court of Appeals - FTC v. Novartis - 2000 - Doan drug product - (9 pages) | http://www.ftc.gov/os/2000/08/novartis.pdf |
| FTC - Final Order - In the Matter of Novartis - Doan drug product | http://www.ftc.gov/os/1999/9905/novaord.htm |
| FTC - Opinion of the MTC in the matter of Novarti's doan drug product - (38 pages) | http://www.ftc.gov/os/1999/9905/novartisopin.pdf |
| FTC - FTC Antitrust Actions in Pharmaceutical Services and Products - Washington D.C. 20580 May 30, 2000 | http://www.ftc.gov/bc/rxupdate.htm |
| FDA - CDER Manual of Policies and Procedures MaPPs | http://www.fda.gov/cder/mapp.htm |
| Legal protection of biotechnical inventions: Frequently Asked questions on scope and objectives of the EU Directive (98/44) | http://europa.eu.int/comm/internal_market/en/indprop/invent/2k-39.htm |
| Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products | http://pharmacos.eudra.org/F2/eudralex/vol-5/pdfs-en/921768en.pdf |
| Draft Guidance on the acceptability of trade names for medicinal products processed through the centralized procedure - 2002 - (5 pages) | http://www.emea.eu.int/pdfs/human/regaffair/032898en.pdf |
| Procedure on the granting of marketing authorisations by central and Eastern European Countries for medicinal products for human use - December 1999 - (18 pages) | http://www.il.waw.pl/centralised_procedure.pdf |
| Note for Guidance on Specifications: test procedures and acceptance criteria for biotechnological/biological products - (17 pages) | http://www.emea.eu.int/pdfs/human/ich/036596en.pdf |
| Note for Guidance on Specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products - (19 pages) | http://www.emea.eu.int/pdfs/human/qwp/282000en.pdf |
| David Reiffen and Michael R. Ward - Generic Drug Industry Dynamics - FTC - February, 2002 - (60 pages) | http://www.ftc.gov/be/workpapers/industrydynamicsreiffenwp.pdf |
| Speech of Timothy J. Muris, Chairman of the Federal Trade Commission, before the Committee on Commerce, Science, and Transportation of Senate Washington, D.C. April 23, 2002 on the pharmaceutical industry | http://www.ftc.gov/os/2002/04/pharmtestimony.htm |
| Competition and Intellectual Property Policy: The Way Ahead - Prepared Remarks of Timothy J. Muris Chairman of the FTC - before American Bar Association Antitrust Section Fall Forum - Washington, DC - November 15, 2001 | http://www.ftc.gov/speeches/muris/intellectual.htm |
| Decision of United States Court of Appeals for the Federal Circuit - 01-1369, -1370 Minnesota Mining and Manufacturing Co. and Riker Laboratories and Alphapharm Pty. Ltd. .v. Barr Laboratories - Hatch Waxman | http://www.ipo.org/2002/IPcourts/3M_v_Barr.htm |
| GAO - Issues in HHS’ Proposed Rule on Confidentiality of Personal Health Information - April 26, 2000 - (27 pages) | http://www.gao.gov/new.items/he00106t.pdf |
| GAO - Prescription Drugs: Spending Controls in Four European Countries (Chapter Report, 05/17/94, GAO/HEHS-94-30). | http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=gao&docid=f:he94030.txt |
| GAO - DOD and VA Health Care - Jointly Buying and Mailing Out Pharmaceuticals Could Save Millions of Dollars - May 25, 2000 - (26 pages) | http://www.presidentshealthcare.org/pdffiles/he00121t.pdf |
| GAO - Prescription Drug Benefits - Applying Private Sector Management Methods to Medicare - March 22, 2000 - (15 pages) | http://www.gao.gov/new.items/he00084t.pdf |
| GAO - Medicare: Considerations for Adding a Prescription Drug Benefit (Testimony, 06/23/99, GAO/T-HEHS-99-153). | http://frwebgate.access.gpo.gov/cgi-bin/useftp.cgi?IPaddress=162.140.64.21&filename=he99153t.txt&directory=/diskb/wais/data/gao |
| FDA - Notice - Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000and 2002 | http://www.fda.gov/cber/genadmin/fr-estab.pdf http://www.pharmcast.com/FederalRegistrar/Yr2002/011402/UserFee011602.htm |
| FDA - Cyber Letters 2000/2001/2002 | http://www.fda.gov/cder/warn/cyber/cyber2000.htm http://www.fda.gov/cder/warn/cyber/cyber2001.htm http://www.fda.gov/cder/warn/cyber/cyber2002.htm |
| 21 CFR (Code of Federal Regulations) Parts 210 and 211 Part 210 - Current Good Manufacturing Practice | http://www.fda.gov/cder/dmpq/cgmpregs.htm |
| FDA - Main page on Good Manufacturing Practices | http://www.fda.gov/cder/dmpq/index.htm |
| FDA - Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections | http://www.fda.gov/cder/dmpq/compliance_guide.htm |
| NIH - NIH Policy for Data and Safety Monitoring - June 10, 1998 | http://grants1.nih.gov/grants/guide/notice-files/not98-084.html |
| FDA - Guidance Financial Disclosure by Clinical Investigators | http://www.fda.gov/oc/guidance/financialdis.html |
| NIH - Guidance on Reporting Adverse Events to Institutional Review Boards for NIH-Supported Multicenter Clinical Trials - June 11, 1999 | http://grants1.nih.gov/grants/guide/notice-files/not99-107.html |
| HHS - Institutional Review Board (IRB) Registration | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/irbs.htm |
| HHS - Informed Consent Checklist / Tips | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/consentckls.htm http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ictips.htm |
| OHRP - Registration of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) | http://ohrp.osophs.dhhs.gov/humansubjects/assurance/regirbt.htm |
| EMA - Annual Report 2001 - (72 pages) | http://www.emea.eu.int/pdfs/general/direct/emeaar/005201en.pdf |
| Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf |
| GAO - Intellectual Property - Industry and Agency Concerns Over Intellectual Property Rights - May 20, 2002 - (13 pages) | http://www.gao.gov/new.items/d02723t.pdf |
| WHO, WHO medicines strategy Expanding access to essential drugs Report by the Secretariat - (6 pages) | http://www.who.int/gb/EB_WHA/PDF/WHA55/ea5512.pdf |
| (federal) Bill S. 812 To amend the Federal Food, Drug, and Cosmetic Act to provide greater access to affordable pharmaceuticals. | http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=107_cong_bills&docid=f:s812is.txt.pdf |
| FDA - A Trial of St. John's Wort (Hypericum perforatum) for the Treatment of Major Depression | http://nccam.nih.gov/ne/press-releases/stjohnswort/q-and-a.htm |
| FDA - Medication Guide Accutane Capsules (isotretinoin) | http://www.fda.gov/cder/drug/infopage/accutane/medicationguide.htm#important warnings |
| FDA - Division of Drug Marketing, Advertising, and Communications - Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs Main Survey Results | http://www.fda.gov/cder/ddmac/dtcindex.htm http://www.fda.gov/cder/ddmac/dtcfllw.htm |
| UNDP - Global initiatives to create technologies for human development - Chapter 5 - (36 pages) | http://www.undp.org/hdr2001/chapterfive.pdf |
| WIPO - Striking a Balance: Patents and Access to Drugs and Health Care | http://www.wipo.int/about-ip/en/studies/publications/health_care.htm |
| Center for Drug Evaluation and Research - 2001 Report to the Nation - Improving Public Health Through Human Drugs - (50 pages) | http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf |
| FDA - 2002 Workshop on Pharmacogenetics / Pharmacogenomics in Drug Development and Regulatory Decision-Making - May 16-17th, 2002 - (65 pages) | http://www.fda.gov/cder/calendar/meeting/phrma52002/workbook.pdf |
| U.S. Preventive Services Task Force (USPSTF) - Recommendations and Rationale Screening for Depression | http://www.ahrq.gov/clinic/3rduspstf/depression/depressrr.htm |
| FDA - Inspection report of Abbott Laboratories (3 pages) | http://www.citizen.org/documents/1619appendix.pdf |
| Institute of Medicine - Shaping the Future for Health Care Without Coverage :Too Little, Too Late - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/Uninsured2FINAL/$file/Uninsured2FINAL.pdf |
| Institute of Medicine - Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care (2002) | http://www.nap.edu/books/030908265X/html/ |
| Institute of Medicine - Exploring the Biological Contributions to Human Health: Does Sex Matter? - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/DoesSexMatter8pager/$file/DoesSexMatter8pager.pdf |
| Institute of Medicine - Exploring the Map of Clinical Research for the Coming Decade: Symposium Summary, Clinical Roundtable, December 2000 - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/CRR8pager3/$file/CRR8pager3.pdf |
| Institute of Medicine - Health and Behavior: The Interplay of Biological, Behavioral, and Societal Influences (May 21, 2001) | http://books.nap.edu/html/health_behavior/ |
| Institute of Medicine - Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (April 17, 2001) - Summary - (6 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/IRB-6Pager/$file/IRB-6Pager.PDF |
| Institute of Medicine - Public Confidence and Involvement in Clinical Research: Symposium Summary, Clinical Roundtable, September 2000 - Summary - (8 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/CRR8pager2/$file/CRR8pager2.pdf |
| Institute of Medicine -Small Clinical Trials: Issues and Challenges (April 10, 2001) - Summary (6 pages) | http://www.iom.edu/iom/iomhome.nsf/WFiles/SmallN6pager/$file/SmallN6pager.pdf |
| Institute of Medicine - Stem Cells and the Future of Regenerative Medicine (September 11, 2001) - 71 pages | http://books.nap.edu/html/stem_cells/report.pdf |
| U.S. DOJ - TAP Pharmaceutical. Products Inc charged with Health Care Crimes | http://www.usdoj.gov/opa/pr/2001/October/513civ.htm |
| White House Commission on Complementary and Alternative Medicine Policy Final Report - March 2002 | http://www.whccamp.hhs.gov/finalreport.html |
| Institutional Animal Care and Use Committee Guidebook - 2002 - (230 pages) | http://grants1.nih.gov/grants/olaw/GuideBook.pdf |
| Report of the International Workshop on In Vitro Methods for Assessing Acute Systemic Toxicity - August 2001 - (370 pages) | http://iccvam.niehs.nih.gov/methods/invidocs/finalall.pdf |
| Guidance Document on Using In Vitro Data to Estimate In Vivo Starting Doses for Acute Toxicity - August 2001 - (100 pages) | http://iccvam.niehs.nih.gov/methods/invidocs/guidance/iv_guide.pdf |
| Current Bibliographies in Medicine 93-1 -Laboratory Animal Welfare | http://www.nlm.nih.gov/pubs/cbm/labanim.html |
| Advisory Committee on Human Radiation Experiments - Final Report | http://tis.eh.doe.gov/ohre/roadmap/achre/report.html |
| Annual Progress Report of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) December 19, 2001 - (21 pages) | http://iccvam.niehs.nih.gov/about/annrpt/annrpt01.doc |
| Public Health Service Policy on Humane Care and Use of Laboratory Animals - (24 pages) | http://grants1.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf |
| Institute
of Laboratory Animal Resources Commission on Life Sciences National Research Council - Guide for the Care and Use of Laboratory Animals - 1996 |
http://www.nap.edu/readingroom/books/labrats/ |
| Published Articles Office of Laboratory Animal Welfare | http://grants1.nih.gov/grants/olaw/references/publishedarticles.htm |
| Animal Welfare Act and Regulations | http://www.nal.usda.gov/awic/legislat/usdaleg1.htm |
| Département fédéral de l’intérieur - L’assurance-maladie sociale Analyse - Séance spéciale du Conseil fédéral du 22 mai 2002 - (55 pages) | http://www.bsv.admin.ch/aktuell/presse/2002/f/02052301.pdf |
| Arrêt du TF sur la cession de créance à la pharmacie de l'assuré contre la caisse-maladie: page 50 à 57 | http://www.bsv.admin.ch/publikat/rkuv/d/rkuv0106.pdf |
| Loi fédérale relative à la recherche sur les embryons surnuméraires et sur les cellules souches embryonnaires (Loi relative à la recherche sur les embryons, LRE) Rapport explicatif sur le projet de loi - Mai 2002 - (86 pages) | http://www.bag.admin.ch/embryonen/bundesgesetz/f/erl_efg.pdf |
| Draft - Loi fédérale Projet relative à la recherche sur les embryons surnuméraires et sur les cellules souches embryonnaires | http://www.bag.admin.ch/embryonen/bundesgesetz/f/entw_efg.pdf |
| Statement of Patricia L. Maher (DOJ) - The Importation of Bulk Counterfeit Pharmaceutical Products - October 3, 2000 | http://www.usdoj.gov/criminal/cybercrime/FDCAover.htm |
| Draft - FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 - February 1998 | http://www.fda.gov/opacom/fedregister/frexport.html |
| Quality King Distributors v. L'Anza Research, 523 U.S. 135, 118 S. Ct. 1125, | http://supct.law.cornell.edu/supct/pdf/96-1470P.ZO |
| Investigators' Reports Maker of Growth Hormone Feels Long Arm of Law - FDA Consumer magazine September-October 1999 | http://www.fda.gov/fdac/departs/1999/599_irs.html |
| Tamar Nordenberg - Direct to You: TV Drug Ads That Make Sense - FDA Consumer magazine - January- February 1998 | http://www.fda.gov/fdac/features/1998/198_ads.html |
| Statement of FTC Commissioner Orson Swindle Concurring in Part and Dissenting in Part in Novartis Corporation et al., Docket No. 9279 | http://www.ftc.gov/os/1999/9905/novaswin.htm |
| FDA Guidance for Industry Consumer-Directed Broadcast Advertisements Questions and Answers | http://www.fda.gov/cder/guidance/1804q&a.htm |
| OECD - The OECD Guidelines for Multinational Enterprises Revision 2000 - (67 pages) | http://www.oecd.org/pdf/M000015000/M00015419.pdf |
| OECD - The OECD Declaration and Decisions on International Investment and Multinational Enterprises : Basic Texts - (35 pages) | http://www.olis.oecd.org/olis/2000doc.nsf/c5ce8ffa41835d64c125685d005300b0/c125692700623b74c1256991003b5147/$FILE/00085743.PDF |
| FTC Complaint against online pharmacies (Viagra, Propecia Prescriptions Promoted With False Medical Claims Consumers' Medical and Financial Data Collected With False Privacy Assurances) | http://www.ftc.gov/os/2000/07/iogcomp.htm |
| FDA - Rule - New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible | http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0237-nfr0001-vol1.pdf |
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| JAAC 66.16 Décision de la Commission fédérale de recours en matière d'alcool - August 20, 2001 | http://www.vpb.admin.ch/franz/contenu_fr.html |
| Proposal for a Regulation and Directive - laying down Community procedures for the authorisation and supervision of medicinal products for human use - November 2001 - (200 pages) | http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf |
| FTC Charges Drug Manufacturers with Stifling Competition in Two Prescription Drug Markets - Hoechst Marion Roussel, Inc. / Andrx Corp.; / Abbott Laboratories / Geneva Pharmaceuticals - March 16, 2000 | http://www.ftc.gov/opa/2000/03/hoechst.htm http://www.ftc.gov/os/2000/03/genevaabbpttanalysis.htm http://www.ftc.gov/os/2000/03/hoechstandrxcomplaint.htm http://www.ftc.gov/os/2000/03/abbottcmp.htm |
| Resolving Competitive Concerns, FTC Agreement Clears $182 Billion Merger of SmithKline Beecham and Glaxo Wellcome - December 18, 2000 | http://www.ftc.gov/opa/2000/12/skb.htm http://www.ftc.gov/os/2000/12/glaxoana.htm http://www.ftc.gov/os/2000/12/glaxotrustagree.pdf http://www.ftc.gov/os/2000/12/glaxosmithklinecmp.pdf |
| FTC - Decision and Order - Docket No. C-3725 - In the Matter of Ciba-Geigy and Sandoz | http://www.ftc.gov/os/1997/9704/c3725.do.htm |
| Communication from the European Communities and their member states to the trips council concept paper relating to paragraph 6 of the Doha declaration on the trips agreement and public health - (8 pages) | http://trade-info.cec.eu.int/europa/2001newround/050-02-rev.pdf |
| Working document tiered pricing for medicines exported to developing countries, measures to prevent their re-importation into the EC market and tariffs in developing countries 22 April, 2002 | http://europa.eu.int/comm/trade/pdf/med_wd.pdf |
| United States Senate Joint Economic Committee, The Benefits of Medical Research and the Role of the NIH, May 2000 - (64 pages) | http://rxpolicy.com/studies/nih-randd-jec.pdf |
| ICH M2 EWG Electronic Common Technical Document Specification- Technical Requirements for registration of pharmaceuticals for human use - February 12, 2002 - (160 pages) | http://www.fda.gov/cder/guidance/5017dft.pdf |
| ICH Q1E - Draft Consensus Guideline Evaluation of Stability Data - 7 February 2002 | http://www.fda.gov/cder/guidance/4983dft.pdf |
| ICH Q1F Draft Consensus Guideline - Stability Data Package for Registration in Climatic Zones III and IV - February 7, 2002 - (5 pages) | http://www.fda.gov/cder/guidance/4984dft.pdf |
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| Swiss Ethics Committee on Non-human Gene Technology - Avis relatif à l’article 120, alinéa 2, de la version française de la constitution fédérale -.(2 pages) | http://www.buwal.ch/stobobio/ekah/pdf/0300f.pdf |
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| Swiss Ethics Committee on Non-human Gene Technology - Evaluation éthique de la technologie «Terminator» - (12 pages) | http://www.buwal.ch/stobobio/ekah/pdf/term_f.pdf |
| Swiss Ethics Committee on Non-human Gene Technology - Prise de position de la CENH sur la réglementation des disséminations d’organismes génétiquement modifiés dans l’environnement - (3 pages) | http://www.buwal.ch/stobobio/ekah/pdf/120500_f.pdf |
| Swiss Ethics Committee on Non-human Gene Technology - Prise de Position provisoire sur le projet de Gen-Lex | http://www.buwal.ch/stobobio/ekah/pdf/050998f.pdf |
| Classeur "Protection des animaux - expériences sur animaux et méthodes de substitution" | http://www.bvet.admin.ch/tierschutz/f/berichte_publikationen/tierversuche/1_index.html |
| Réorientation du droit suisse sur la protection des animaux Rapport du groupe de travail à l’intention de l’Office vétérinaire fédéral du 12 août 1998 | http://www.bvet.admin.ch/tierschutz/f/berichte_publikationen/tierschutzpolitik/98-10-01-bericht.html |
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| Federal Veterinary Office - Form A and Form B for experiments on animals | http://www.bvet.admin.ch/tierschutz/d/vollzugshilfen/tv-formulare/formular_a_e.pdf http://www.bvet.admin.ch/tierschutz/e/vollzugshilfen/tv-formulare/c_form_engl.pdf |
| Final Report - Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 | http://www.fda.gov/cder/reports/prescriptionInfo/default.htm |
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| Rapport du 18 mai 1999 de la Commission des affaires juridiques du Conseil national Avis du Conseil fédéral du 20 septembre 1999 | http://www.ofj.admin.ch/themen/tiere/stellungnahme-br-f.pdf |
| Révision
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| Débat parlementaire sur l'initiative relative au statut de l'animal | http://www.parlament.ch/ab/frameset/d/s/4604/17669/d_s_4604_17669_17799.htm http://www.parlament.ch/ab/frameset/d/s/4612/49803/d_s_4612_49803_50511.htm?DisplayTextOid=50512 http://www.parlament.ch/ab/data/d/s/4612/49803/d_s_4612_49803_50511.htm |
| Rapport de la Commission des affaires juridiques (CAJ) du 18 mai 2000 sur l'initiative "Les animaux dans l'orde juridique suisse" (CAJ-CE) | http://www.parlament.ch/afs/data/f/bericht/1999/f_bericht_s_k25_0_19990467_01.htm#a2 |
| Message du Conseil fédéral concernant les initiatives populaires fédérales «pour un meilleur statut juridique des animaux (Initiative pour les animaux)» et «Les animaux ne sont pas des choses!» du 25 avril 2001 - (19 pages) | http://www.admin.ch/ch/f/ff/2001/2390.pdf |
| TFA - Federal Insurance Tribunal - court decision on musicotherapy - I 510/00 Mh - April 29, 2002 | http://wwwsrv.bger.ch/cgi-bin/AZA/MapProcessorCGI_AZA?mapfile=pull/ConvertDocFrameCGI.map&ri=fr&lang=fr&ds=AZA_pull&d=29.04.2002_I_510%2f00&pa=2%7emusicotherapie%4010%7emusicotherapie%404%7e& |
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| Council Directive of 7June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (88/320/EEC) | http://europa.eu.int/eur-lex/en/consleg/pdf/1988/en_1988L0320_do_001.pdf |
| OTA - Unconvention Cancer Treatments - September 1990 OTA-H-405 - (297 pages) | http://www.ota.nap.edu/pdf/data/1990/9044.PDF |
| OTA - Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues OTA-BP-H-163 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9524/9524.PDF |
| OTA - The Effectiveness of Research and Experimentation Tax Credits - 1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9558/9558.PDF |
| OTA - Federal Technology Transfer and the Human Genome Project - OTA-BP-EHR-162 - 1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9526/9526.PDF |
| OTA - Impacts of Antibiotic-Resistant Bacteria OTA-H-629 -1995 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9503/9503.PDF |
| OTA - Defensive Medicine and Medical Malpractice - OTA-H-602 - 1994 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1994/9405/9405.PDF |
| OTA - International Comparisons of Administrative Costs in Health Care - OTA-BP-H-135 - 1994 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1994/9417/9417.PDF |
| OTA - International Health Statistics: What the Numbers Mean for the United States - OTA-BP-H-116 - 1994 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1994/9418/9418.PDF |
| OTA - Researching Health Risks - OTA-BBS-570 - 1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9352/9352.PDF |
| OTA - Drug Labeling in Developing Countries - 1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9321/9321.PDF |
| OTA - Pharmaceutical R&D: Costs, Risks, and Rewards - OTA-H-522 - 1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9336/9336.PDF |
| OTA - Biomedical Ethics in U.S. Public Policy OTA-BP-BBS-105 -1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9312/9312.PDF |
| Joint Economic Committee - Health Insurance Tax Credits: the Wrong Prescription for the Uninsured - February 13, 2002 - (13 pages) | http://jec.senate.gov/Documents/106th/Reports/hitaxcredit13feb2002.pdf |
| The Evaluation of Abstinence Education Programs Funded Under Title V Section 510: Interim Report | http://aspe.hhs.gov/hsp/abstinence02/ http://aspe.hhs.gov/hsp/abstinence02/execsum.htm#TOC |
| Rapport sur le Cannabis de la Commission fédérale pour les questions liées aux drogues - CFLD - Septembre 1999 - (114 pages) | http://www.bag.admin.ch/sucht/publikationen/f/cannabis.pdf |
| Assurance-maladie : Mesures et train de réformes du Conseil fédéral et du DFI - July 3, 2002 | http://www.ofas.admin.ch/aktuell/presse/2002/f/02070303.htm http://www.ofas.admin.ch/aktuell/presse/2002/f/02070304.pdf http://www.ofas.admin.ch/aktuell/presse/2002/f/02070307.pdf http://www.ofas.admin.ch/aktuell/presse/2002/f/02070308.pdf |
| Swissmedic - Evolution du nombre de prescriptions de RITALINE® (méthylphénidate) dans le canton de Neuchâtel entre 1996 et 2000 - (13 pages) | http://www.swissmedic.ch/files/pdf/Enqu%EAte_Ritaline_Neuch%E2tel.pdf |
| FDA - Guidance for Industry Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics - (7 pages) | http://www.fda.gov/cder/guidance/4932dft.PDF |
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| OTA - The Biology of Mental Disorders OTA-BA-538 - September 1992 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1992/9237/9237.PDF |
| OTA - Does Health Insurance Make a Difference? OTA-BP-H-99 - September 1992 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1992/9212/9212.PDF |
| OTA - Biotechnology in a Global Economy - OTA-BA-494 - October 1991 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1991/9110/9110.PDF |
| OTA - Review of a Protocol for a Study of Reproductive Health Outcomes Among Women Vietnam Veterans - December 1991 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1991/9135/9135.PDF |
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| WHO - Operational Guidelines for Ethics Committees That Review Biomedical Research - 2000 - (39 pages) | http://www.who.int/tdr/publications/publications/pdf/ethics.pdf |
| Governance arrangements for NHS Research Ethics Committees - July 2001 - (35 pages) | http://www.doh.gov.uk/research/documents/gafrec.pdf |
| South West Local Research Ethics Committees Common Application Form Guidance Notes - August 2001 - (19 pages) | http://www.doh.gov.uk/research/swro/rd/ethics/ethforms/ethguid.pdf |
| Australian commonwealth Department of Health and Aged Care - Human Research Ethics Committees and the Therapeutic Goods Legislation - June 2001 - (66 pages) | http://www.health.gov.au/tga/docs/pdf/unapproved/hrec.pdf |
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| New Zealand - Guide on Codes of Ethical Conduct - May 2002 (28 pages) | http://202.78.129.207/biosecurity/animal-welfare/naeac/papers/naeaccec.pdf |
| Proceedings of the 5th European Conference of National Ethics Committees (COMETH) 4-5 September 2000, - Strasbourg - (81 pages) | http://www.legal.coe.int/bioethics/gb/pdf/5e_conference.pdf |
| Ordonnance de l'OFSP du 8 novembre 1996 sur les précurseurs et autres produits chimiques utilisés pour la fabrication de stupéfiants et de substances psychotropes (Ordonnance de l'OFSP sur les précurseurs, O Prec-OFSP) | http://www.admin.ch/ch/f/rs/8/812.121.31.fr.pdf |
| Ordonnance du 8 mars 1999 sur la prescription médicale d'héroïn | http://www.admin.ch/ch/f/rs/8/812.121.6.fr.pdf |
| Loi fédérale du 21 mars 1969 sur le commerce des toxiques (Loi sur les toxiques | http://www.admin.ch/ch/f/rs/8/813.0.fr.pdf |
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| Loi fédérale du 18 décembre 1998 sur la procréation médicalement assistée (LPMA) | http://www.admin.ch/ch/f/rs/8/814.90.fr.pdf |
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| Ordonnance du 4 décembre 2000 sur la Commission nationale d'éthique dans le domaine de la médecine humaine (OCNE) | http://www.admin.ch/ch/f/rs/8/814.903.fr.pdf |
| Ordonnance du 25 août 1999 sur l'utilisation d'organismes dans l'environnement (Ordonnance sur la dissémination dans l'environnement, ODE) | http://www.admin.ch/ch/f/rs/8/814.911.fr.pdf |
| Ordonnance du 25 août 1999 sur l'utilisation des organismes en milieu confiné (Ordonnance sur l'utilisation confinée, OUC) | http://www.admin.ch/ch/f/rs/8/814.912.fr.pdf |
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| Ordonnance du 26 juin 1995 sur la valeur nutritive (ONutr); RS 817.021.55. | http://www.admin.ch/ch/f/rs/8/817.021.55.fr.pdf |
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| Ordonnance du 26 juin 1995 sur les cosmétiques (OCos); RS 817.042.1 | http://www.admin.ch/ch/f/rs/8/817.042.1.fr.pdf |
| Federal Senate - Modification of the Federal law on narcotics | http://www.parlament.ch/ab/frameset/f/s/4611/45079/f_s_4611_45079_45107.htm |
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| COMMUNICATION
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| Center
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| Swiss Technology Assessment - Citizen Panel Report - Genetic Technology and Nutrition: - 4 - 7 June 1999 in Berne - (52 pages) | http://www.ta-swiss.ch/www-remain/reports_archive/publications/1999/ta_p_1_99_e.pdf |
| Medical Devices Ordinance (MDO) Information on Article 13 Reporting of serious incidents | http://www.bag.admin.ch/md/pdf/VI-Indus-InfoE.pdf |
| Check list of documents required - Annonce d'investigations cliniques avec des dispositifs médicaux | http://www.bag.admin.ch/md/pdf/kl-checklistdfie.pdf |
| European Committee for Standardization - CEN - home page | http://www.cenorm.be/ |
| Liste des tous les stupéfiants avec leurs numéros EAN-A, pharmacodes et leurs distributeurs -Appendice a /art. 1 OStup-OFSP- | http://www.bag.admin.ch/betm/f/verz/verz_a.pdf |
| Liste des stupéfiants prohibés -Appendice d /art. 4 OStup-OFSP | http://www.bag.admin.ch/betm/f/verz/verz_ad.pdf |
| Directives techniques sur le don de sang - | http://www.bag.admin.ch/heilmitt/biologik/gesetze/f/nat_rlin.pdf |
| Le Conseil fédéral veut réglementer la recherche sur les cellules souches embryonnaires dans une loi fédérale spécifique - Press release - November 21, 2001 | http://www.bag.admin.ch/dienste/medien/2001/f/01112137.htm |
| Commission d'experts du secret professionnel en matière de recherche médicale - Rapport d'activité pour les années 1998, 1999, 2000 - (25 pages) | http://www.bag.admin.ch/themen/weitere/expkmedf/t_ber_f.pdf |
| Le Conseil fédéral met en vigueur les ordonnances relatives à la loi sur les produits thérapeutiques - Press release of October 17, 2001 | http://www.bag.admin.ch/dienste/medien/2001/f/01101731.htm |
| Draft - New Swiss Federal law on patents - (Loi sur les brevets, LBI) | http://www.ejpd.admin.ch/Doks/vl/patg_ges-f.pdf |
| Explicative report regarding the draft new Federal Law on patents - (93 pages) | http://www.ejpd.admin.ch/Doks/vl/patg_ber-f.pdf |
| Annual report of the Federal Institute for Intellectual Property - (29 pages) | http://www.ige.ch/F/institut/pdf/i102jb01f.pdf |
| Federal Department of Justice and Police - Biotechnologie et droit des brevets: Rapport sur la brevetabilité des inventions concernant les organismes - August 1993 - (52 pages) | http://www.ige.ch/F/jurinfo/pdf/j140_biof.pdf |
| Council of Europe, Convention for the Protection of Human Rights and Fundamental Freedoms as amended by Protocol No. 11 with Protocol Nos. 1, 4, 6 and 7 | http://www.echr.coe.int/Convention/webConvenENG.pdf |
| Council of Europe - Public Health page | http://www.coe.fr/soc-sp/sante/default_eng.htm |
| Public Health Committee - Committee of experts on cosmetic products -"Indicative catalogue of criteria for delimiting borderline situations between cosmetic and medicinal products" | http://www.coe.fr/soc-sp/sante/Cosm%20claims%20catalogue.htm |
| Council of Europe - Cosmétiques naturels - Notice of information to consumers | http://www.coe.fr/soc-sp/sante/nat%20cosm.htm |
| List of medicines subject to prescription, 2000 edition | http://www.coe.fr/soc-sp/sante/Alpha%20List%202000%20E.zip |
| Council of Europe - Committee of Ministers - Resolution AP(2000) on the classification of medicines which are obtainable only on medical prescription - March 15, 2000 | http://cm.coe.int/ta/res/resAP/2000/2000xp1.htm |
| Council of Europe - Committee of Ministers . Resolution AP (99) 2- on warning phrases for certain categories of medicines | http://www.coe.fr/cm/ta/res/resAP/1999/99xp2.htm |
| Council of Europe - Committee of Ministers - Resolution AP (96) - on the declaration of excipients present in pharmaceutical products - October 2, 1996 | http://cm.coe.int/ta/res/1996/96xp1.html |
| Public Health Committee - Committe of experts on pharmaceutical questions - Note from the Austrian Delegation on the requirements applying to prescriptions - Medicines for human use except narcotics | http://www.coe.fr/soc-sp/sante/97spt19reve.zip |
| Public Health Committe - Committee of experts on pharmaceutical questions - Final Report on Generic Medicines - April 2000 | http://www.coe.fr/soc-sp/sante/CD-P-SPT%20(2000)%2027%20E%20-generic%20medicines.zip |
| Council of Europe - comparisons of regulations applying to vitamins | http://www.coe.fr/soc-sp/sante/CD-P-SPT%20(98)%2024E%20-Vitamin%20products.zip |
| Public Health Committee - Committee of experts on pharmaceutical questions - Final Report on the importation of unregistered medicines - Multicountry comparisons - April 2000 | http://www.coe.fr/soc-sp/sante/SPT28E%20-%20médicaments%20non%20enregistrés%20-%20Autriche.zip |
| Council of Europe's Policy Statements concerning nutrition, food safety and Consumer Health - Technical document - Guidelines concering scientific substantiation of health-related claims for functional food | http://www.coe.fr/soc-sp/sante/functfood.ZIP |
| Council of Europe - Public Health Committee - Energy Drinks - Information Note to Consumers - May 2001 | http://www.coe.fr/soc-sp/sante/energ_drinks.htm |
| FDA, Acupuncture needle status changed - April 1, 1996 | http://www.fda.gov/bbs/topics/ANSWERS/ANS00722.html |
| FDA, Devices classification - previous correspondance | http://www.fda.gov/cdrh/devadvice/21.html#contents |
| FDA - Product Code Classification Database | http://www.fda.gov/cdrh/prodcode.html |
| FDA - Good Manufacturing Practices (GMP) / Quality System (QS) Regulation | http://www.fda.gov/cdrh/devadvice/32.html#contents |
| FDA - CDRH Annual Report Fiscal Year 2000 | http://www.fda.gov/cdrh/annual/fy2000/annualreport-2000.pdf |
| FDA - Breast Implants - An Information Update - 2000 - (82 pages) | http://www.fda.gov/cdrh/breastimplants/indexbip.PDF |
| FDA - Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified CornJune 11, 2001 - (24 pages) | http://www.cdc.gov/nceh/ehhe/Cry9cReport/cry9creport.pdf |
| FDA - FDA documents concerning StarLink | http://www.epa.gov/scipoly/sap/index.htm#july |
| FDA - Food and Cosmetic Guidance Documents | http://www.cfsan.fda.gov/~dms/guidance.html |
| FDA - Guidance for Industry - Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements | http://www.cfsan.fda.gov/~dms/ssaguide.html |
| FDA - Draft - Guidance for Industry - Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering - January 2001 | http://www.cfsan.fda.gov/~dms/biolabgu.html |
| FDA - Report on Consumer Focus Groups on Biotechnology | http://www.cfsan.fda.gov/~comm/biorpt.html |
| FDA - Food and Cosmetics International Activities | http://www.cfsan.fda.gov/~comm/intl-toc.html |
| FDA - A New Kind of Fish Story: The Coming of Biotech Animals - FDA Magazine - January February 2001 | http://www.cfsan.fda.gov/~dms/fdbiofsh.html |
| FDA - Dietary supplements - home page | http://www.cfsan.fda.gov/~dms/supplmnt.html |
| FDA - Overview of Dietary Supplements - FAQs | http://www.cfsan.fda.gov/~dms/supplmnt.html |
| FDA - Claims That Can Be Made for Conventional Foods and Dietary Supplements | http://www.cfsan.fda.gov/~dms/hclaims.html |
| FDA - A Food Labeling Guide--Appendix C | http://www.cfsan.fda.gov/~dms/flg-6c.html |
| FDA - CFR 21 § 101.72 - Health claims: calcium and osteoporosis. | http://www.cfsan.fda.gov/~lrd/cf101-72.html |
| FDA - Bovine Spongiform Encephalopathy (BSE) | http://www.fda.gov/cber/bse/bse.htm |
| FDA - CBER Guidances / Guidelines / Points to Consider | http://www.fda.gov/cber/guidelines.htm |
| FDA - CBER - Blood Publications | http://www.fda.gov/cber/blood/bldpubs.htm |
| FDA - CBER - Tissue Related Documents | http://www.fda.gov/cber/tissue/docs.htm |
| FOPH - Une vitamine B2 produite par génie génétique est autorisée - September 2001 | http://www.bag.admin.ch/verbrau/aktuell/Medienmitteilungen/medienmitteilung_vit_b2_f.pdf |
| FOPH - Irradiation des denrées alimentaires | http://www.bag.admin.ch/verbrau/lebensmi/infos/f/fakten/irradiation_denrees_alimentaires.pdf |
| FOPH - Aliments fonctionnels - Information page | http://www.bag.admin.ch/verbrau/lebensmi/infos/f/fakten/aliments_fonctionnels.pdf |
| Draft - Ordinance on Foodstuffs (modification de l'ordonnance sur les denrées alimentaires) | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/revisionen/f/odal.pdf |
| Report regarding the proposed change to the ordinance on foodstuffs - (31 pages) | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/revisionen/f/commentaire_odal.pdf |
| Draft -Modifications of the ordinance on nutritive value | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/revisionen/f/onutr.pdf |
| Report on the proposed change of the ordinance on nutritive value | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/revisionen/f/commentaire_onutr.pdf |
| FOPH - Modification de l’ordonnance sur les denrées alimentaires (ODAl) - Analyse d'impact de la réglementation | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/revisionen/f/analyse_impact_odai.pdf |
| Séparation des OGM dans les filières des denrées alimentaires - Recherche effectuée sur mandat de l’Office fédéral de la santé publique | http://www.bag.admin.ch/verbrau/lebensmi/gvo/f/prognos_kurzf.pdf |
| FOPH - Information on the label of GMO products | http://www.bag.admin.ch/verbrau/lebensmi/gvo/f/prospectus.pdf |
| FOPH - Autorisation de mise sur le marché d'aliments spéciaux d'un genre nouveau - October 6, 1999 | http://www.bag.admin.ch/dienste/medien/1999/f/99100635.htm |
| FOPH - Vitamines et sels minéraux dans les denrées alimentaires - mentions autorisées | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/f/vitamines_sels_mineraux_mentions.pdf |
| FOPH - Aide-mémoire pour l‘enregistrement de nouveaux produits | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/f/merkblatt_neuprodukten.htm |
| FOPH - Demande d'autorisation pour la mise sur le marché d'une denrée alimentaire | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/f/demande_autorisation_denree_alimentaire.pdf |
| Aide-mémoire pour l‘enregistrement des compléments alimentaires (food supplement) | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/f/merkblatt_nahrungsergaenzungen.htm |
| FOPH - Aide-mémoire pour l‘enregistrement des aliments de complément/aliments de supplément (ex. produits pour sportifs) | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/f/merkblatt_ergaenzungsnahrungen.htm |
| FOPH - list of autorizations granted for new food from July to December 2000 | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/d_f/2_sem_2000_bnl_aan.pdf |
| FOPH - Authorizations granted for special food - from July to December 2000 | http://www.bag.admin.ch/verbrau/lebensmi/lmrecht/d_f/2_sem_2000_bs_aas.pdf |
| FOPH - Information letter n° 64 on borderline situations regarding cosmetic products - February 14, 2001 | http://www.bag.admin.ch/verbrau/gebrauch/is/f/lettre_information_64.pdf |
| FOPH - Information no 8/97 - Indication du lot selon art. 23 al. 1 let. f Ous/Recommandation de la Commission de la concurrence au sens de l‘art. 45 de la Loi sur les cartels à l’adresse de l‘Office fédéral de la santé publique | http://www.bag.admin.ch/verbrau/gebrauch/is/f/infoschreiben_8.htm |
| Liste des membres de la Commission fédérale de l'alimentation | http://www.admin.ch/ch/f/cf/ko/index_50.html |
| Projet national « Santé et alimentation » - Ensemble pour une alimentation saine - October 24, 2001 | http://www.bag.admin.ch/dienste/medien/2001/f/01102433.htm |
| Swiss Ethics Committee on Non-human Gene Technology - Rapport de la Commission fédérale d'éthique pour le génie génétique dans le domaine non humain - Evaluation éthique de la technologie «Terminator» | http://www.buwal.ch/stobobio/ekah/pdf/term_f.pdf |
| FDA - Food Labeling; Health Claims and Label Statements for Dietary Supplements - Strategy for Implementation of Pearson Court Decision | http://www.fda.gov/ohrms/dockets/98fr/120199b.pdf |
| Swiss Department of Home Affairs - Rapport de consultation concernant les ordonnances sur les produits thérapeutiques - October 17, 2001 - (18 pages) | http://www.bag.admin.ch/heilmitt/aktuell/d/verordnungen/Rapport%20de%20consultation%20OPT%2017.10.01%20zum%20Druck-f.pdf |
| ATF 99 Ia 370 - decision of the Swiss Federal Tribunal regarding sale by Migro of Vitamins C | http://www.eurospider.ch/buge3/index/99_I.html |
| ATF 127 II 91 - decision of the Swiss Federal Tribunal regarding an advertisement for milk as preventing osteoporose | http://www.eurospider.ch/buge3/index/127_II.html |
| Special Programme for Research and Training in Tropical Diseases (TDR) - home page - "TDR focuses on neglected infectious diseases that disproportionally affect poor and marginalized populations" | http://www.who.int/tdr/ |
| United Nations Development Programme - home page - "UNDP provides funds; helps developing countries attract and use aid effectively" | http://www.undp.org/ |
| World Bank - home page - "one of the world's largest sources of development assistance. In Fiscal Year 2001, the institution provided more than US$17 billion in loans to its client countries" | http://www.worldbank.org/ |
| World Bank - Health, Nutrition, and Population Sector Strategy Paper - (93 pages) | http://wbln0018.worldbank.org/HDNet/hddocs.nsf/c840b59b6982d2498525670c004def60/80ac87ad5b7910c4852568f20051bdcc/$FILE/hnp.pdf |
| FDA - Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999 - | http://www.fda.gov/cder/reports/race_ethnicity/race_ethnicity_report.htm |
| PERF - Pan European Regulatory Forum - home page - "The ultimate aim of this programme is the transposition of all technical regulations and European technical acts into the national legislation of central and eastern European countries (CEECs)" | http://perf.eudra.org/ |
| European Commission - Pharmaceuticals in the European Union - Information brochure - (42 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/pharmaeu.pdf |
| European DG Enterprise - Inventory of Community and national incentive measures to aid the research, marketing, development and availability of orphan medicinal products - (17 pages) | http://pharmacos.eudra.org/F2/orphanmp/doc/inventory/Inventory-en.pdf |
| Draft Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another, revision December 2000 | http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2000/dec/format-content-rev3.pdf |
| COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts | http://pharmacos.eudra.org/F2/orphanmp/doc/rev1/en1.pdf |
| REPORT on the communication from the Commission on the Single Market in Pharmaceuticals (COM(98)0588 - C4-0127/99) - April 21, 1999 - (18 pages) | http://pharmacos.eudra.org/F2/smarket/pdf/cemaipen.pdf |
| Third Round Table "Completing the Single Pharmaceutical Market" - December 7, 1998, (77 pages) | http://pharmacos.eudra.org/F2/smarket/pdf/Roundt3.pdf |
| Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.europa.eu.int/eur-lex/en/lif/dat/2001/en_301L0020.html |
| European Commission, Provisions of a directive on traditional medicinal products | http://www.mca.gov.uk/ourwork/licensingmeds/herbalmeds/echerb.pdf |
| The rules governing medicinal products in the European Union - Pharmaceutical legislation- Medicinal products for human use- Volume I -1998 - (294 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol1/vol1en.pdf |
| Notice to Applicants Volume 2A - Procedures for marketing autorisation | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2aen.pdf |
| Notice to Applicants - Volume 2B - Medicinal products for human use - Presentation and content of the dossier - 1998 - (206 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2ben.pdf |
| Guidelines - Volume 3A - Medicinal products for human use - Quality and biotechnology - 1998 - (417 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/vol3aen.pdf |
| Guidelines - Volume 3B - Medicinal products for human use - Safety, environment and information - 1998 - (240 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3ben.pdf |
| Guidelines - Volume 3C - Medicinal products for human use - Efficacy - 1998 - (402 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3cen.pdf |
| Volume 4 - Good manufacturing practices - Medicinal products for human and veterinary use - (153 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol4/vol4en.pdf |
| European Commission - Revision of Annex 14 to the EU Guide to Good Manufacturing Practice - Manufacture of medicinal products1 derived from human blood or human plasma - (7 pages) | http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/gmpan14_en.pdf |
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| FTC Antitrust Actions in health care services and products - June 2001 | http://www.ftc.gov/bc/hcindex/hcupdate.pdf |
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- Analysis to Aid Public Comment - proposed consent order with Hoechst
Marion Roussel, Inc. (“HMR”), Carderm Capital, L.P. (“Carderm”), and Andrx Corporation (“Andrx”) - (7 pages9 |
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| FTC - Complaint - against Schering-Plough Corporation, Upsher-Smith Laboratories, American Home Products Corporation, | http://www.ftc.gov/os/2001/04/scheringpart3cmp.pdf |
| FTC - Antitrust Guidelines for Collaborations Among Competitors - April 2000 - (39 pages) | http://www.ftc.gov/os/2000/04/ftcdojguidelines.pdf |
| FTC - Marketer of Herbal Supplement Products Agrees to Settle FTC Charges That Safety and Health Benefit Claims Were False | http://www.ftc.gov/opa/2001/12/chrisenterprises2.htm |
| FTC - Statement of the Federal Trade Commission's Bureau of Consumer Protection On the National Cancer Institute's Report on Cigarette Testing Method - November 27, 2001 | http://www.ftc.gov/opa/2001/11/ncistudy.htm |
| The Directory of Federal and State Nutrition Monitoring and Related Research Activities Interagency Board for Nutrition Monitoring and Related Research- Nutrition Monitoring in the United States - April 2000 - (268 pages) | http://www.cdc.gov/nchs/data/misc/direc-99.pdf |
| Healthy People 2010: Volume II (second edition) (664 pages) - Chapter 17 on Medical Product Safety - (20 chapters) | http://www.health.gov/healthypeople/Document/pdf/Volume2/17Medical.pdf |
| National Cancer Institute. Health effects of exposure to environmental tobacco smoke: the report of the California Environmental Protection Agency. Smoking and tobacco control monograph no. 10. Bethesda - 1999 - (NIH publication no. 99-4645). | http://rex.nci.nih.gov/NCI_MONOGRAPHS/MONO10/MONO10.HTM |
| ational Cancer Institute. Smokeless Tobacco or Health - Monograph no. 10. Bethesda - September 1992 - | http://rex.nci.nih.gov/NCI_MONOGRAPHS/MONO2/MONO2.HTM |
| National Institutes of Health - Changes in Cigarette-Related Disease Risks and Their Implications for Prevention and Control (February 1997) | http://rex.nci.nih.gov/NCI_MONOGRAPHS/MONO8/MONO8.HTM |
| FTC - Statement of Susan A. Creighton, Deputy Director, Bureau of Competition Regarding FTC Settlement with Hearst Corporation - November 20, 2001 - news release | http://www.ftc.gov/opa/2001/11/hearst.htm |
| FTC - Five Manufacturers of Over-the-Counter Analgesic Products Agree to Settle Charges of Mislabeling Certain Products as "Made in USA" - November 6, 2001 - press release | http://www.ftc.gov/opa/2001/11/musa.htm |
| FTC -FTC Staff Comments on FDA’s Plans to Collect Information on Direct-To-Consumer Prescription Drug Advertising - September 24, 2001 - | http://www.ftc.gov/be/v010008.htm |
| Dennis Murphy, Theodore H. Hoppock and Michelle K. Rusk - A Generic Copy Test of Food Health Claims in Advertising - November 1998 | http://www.ftc.gov/os/1998/9811/netfood.pdf |
| Bureau of Economics with the Bureau of Competition and the Bureau of Consumer Protection - Competition and the Financial Impact of the Proposed Tobacco Industry Settlement - September 1997 | http://www.ftc.gov/reports/tobacco/ndoc95.pdf |
| FTC - Dietary Supplements: An Advertising Guide for Industry - (32 pages) | http://www.ftc.gov/bcp/conline/pubs/buspubs/dietsupp.pdf |
| FTC - Enforcement Policy Statement on Food Advertising - May 1994 | http://www.ftc.gov/bcp/policystmt/ad-food.htm |
| FTC - List of documents on tobacco | http://www.ftc.gov/bcp/menu-tobac.htm |
| U.S. Patent and Trademark Office - PCT Administrative Instructions - (85 pages) | http://www.uspto.gov/web/offices/pac/dapps/pct/pctadmin.pdf |
| U.S. Patent and Trademark Office - Provisional patents information | http://www.uspto.gov/web/offices/pac/provapp.htm |
| US Patent and Trademark Office - Manual of Patent Examining Procedure | http://www.uspto.gov/web/offices/pac/mpep/mpep_e8_pdfs_zipped.zip |
| US Patent and Trademark Office - list of cases in alphabetical order | http://www.uspto.gov/web/offices/com/sol/foia/bpai.htm |
| US Patent and Trademark Office - Changes to Implement 20-Year Patent Term and Provisional Applications - June 1995 | http://www.uspto.gov/web/offices/com/doc/uruguay/20_year_term.html |
| Patent and Trademark Office Report on Recommendations from the April 1998 Conference on Database Protection and Access Issues - July 1998 | http://www.uspto.gov/web/offices/dcom/olia/dbconf/dbase498.htm |
| United States Patent and Trademark Office - Eighteen-Month Publication of Patent Applications | http://www.uspto.gov/web/offices/pac/pgpub.htm |
| U.S. Patent and Trademark Office - Fee Schedule | http://www.uspto.gov/web/offices/ac/qs/ope/1999/fee20011001.htm |
| US Patent and Trademark Office - Patent Search | http://www.uspto.gov/patft/index.html |
| Drug Enforcement Agency - Schedules of controlled substances | http://www.usdoj.gov/dea/pubs/schedule.pdf |
| US Drug Enforcement Administration - DEA - Information about Ritalin / Methylphenidate | http://www.usdoj.gov/dea/concern/abuse/chap4/stimula/methylph.htm |
| US Drug Enforcement Administration - DEA - Information about Anorectic Drugs | http://www.usdoj.gov/dea/concern/abuse/chap4/stimula/anorecti.htm |
| US Department of Justice - Tobacco news | http://www.usdoj.gov/civil/cases/tobacco/index.htm |
| Pontifical Academy for life - Declaration on the production and the scientific and therapeutic use of human embryonic stem cells | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html |
| Pontifical Academy for life - statement on the so-called "morning-after pill" | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20001031_pillola-giorno-dopo_en.html |
| Pontifical Academy for life - Reflections on Cloning | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_30091997_clon_en.html |
| Pontifical Academy for life - identity and Statute of Human Embryos | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_06041998_embrione_en.html |
| CBO - The Proposed Tobacco Settlement: Issues from a Federal Perspective, April 1998 | http://www.cbo.gov/showdoc.cfm?index=407&sequence=0&from=1 |
| GAO - Adverse Drug Events, The Magnitude of Health Risk Is Uncertain Because of Limited Incidence Data, GAO report, January 2000 | http://www.gao.gov/archive/2000/he00053t.pdf |
| ·GAO - Adverse Events: Surveillance Systems for Adverse Events and Medical Errors, February 2000, | http://www.gao.gov/archive/2000/he00061t.pdf |
| GAO - Attention Disorder Drugs Few Incidents of Diversion or Abuse Identified by Schools, September 2001, | http://www.gao.gov/new.items/d011011.pdf |
| GAO - Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids, July 1999, | http://www.gao.gov/archive/1999/h299090.pdf |
| GAO - Drug Abuse: Efforts Under Way to Determine Treatment Outcomes, February 2000 | http://www.gao.gov/archive/2000/he00060t.pdf |
| GAO - Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women, January 2001 | http://www.gao.gov/new.items/d01286r.pdf |
| GAO - Health Products for Seniors: Potential Harm From "Anti-Aging" Products, September 2001, | http://www.gao.gov/new.items/d011139t.pdf |
| GAO - Human Fetal Tissue: Acquisition for Federally Funded Biomedical Research, October 2000, | http://www.gao.gov/archive/2000/d010065r.pdf |
| GAO - Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain, May 2001 | http://www.gao.gov/new.items/d01775t.pdf |
| GAO - Mutual Recognition Agreement: Update on the Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Good Manufacturing Practice Regulatory Systems, August 1999 | http://161.203.16.4/paprpdf2/162604.pdf |
| GAO - Mutual Recognition Agreement: Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Inspection Programs, February 1999 | http://161.203.16.4/paprpdf2/161744.pdf |
| GAO - NIH Clinical Trials: Various Factors Affect Patient Participation, October 1999 | http://www.gao.gov/archive/1999/he99182.pdf |
| GAO - NIH Research: Improvements Needed in Monitoring Extramural Grants, May 2000 | http://www.gao.gov/archive/2000/h100139.pdf |
| GAO - Women's Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement, July 2001, | http://www.gao.gov/new.items/d01754.pdf |
| GAO - ·Women's Health: NIH Has Increased Its Efforts to Include Women in Research, May 2000, | http://www.gao.gov/archive/2000/he00096.pdf |
| GAO - Vaccine Injury Trust Fund: Revenue Exceeds Current Need for Paying Claims, March 2000, | http://www.gao.gov/archive/2000/he00067.pdf |
| GAO - Prescription Drugs, Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs, August 2000, | http://www.gao.gov/archive/2000/he00140.pdf |
| GAO - Prescription Drugs: Drug Company Programs Help Some People Who Lack Coverage, November 2000 | http://www.gao.gov/new.items/d01137.pdf |
| GAO - Pediatric Drug Research: Substantial Increase in Studies of Drugs for Children, But Some Challenges Remain, May 2001, | http://www.gao.gov/new.items/d01705t.pdf |
| Judgment of the Court (Fifth Chamber) of 30 November 1983 - against Leendert van Bennekom - Case 227/82 - Concept of "Medicinal products" | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 7 February 1984. Duphar BV - Case 238/82 - Health-care scheme - Compatibility with the Treaty of restrictions on access to certain medicinal preparations | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court (Fifth Chamber) of 21 March 1991 - against Jean-Marie Delattre -Case C-369/88. - Concepts of "disease" or "illness" and "medicinal product" | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 31 October 1974 - Centrafarm BV et Adriaan de Peijper v Sterling Drug Inc. - Case 15-74 - Reference for a preliminary ruling: Hoge Raad - Netherlands - Parallel patents. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment
of the Court of 20 May 1976 - Adriaan de Peijper, Managing Director of
Centrafarm BV - Case 104-75 Reference for a preliminary ruling: Kantongerecht Rotterdam - Netherlands. |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment
of the Court of 10 October 1978 - Centrafarm BV v American Home Products
Corporation - Case 3/78- Reference for a preliminary ruling:
Arrondissementsrechtbank Rotterdam - Netherlands. Serenid - Seresta. |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 14 July 1981 - Merck & Co. Inc. v Stephar BV and Petrus Stephanus Exler. - Case 187/80 - Reference for a preliminary ruling: Arrondissementsrechtbank Rotterdam - Netherlands. - Patents - Pharmaceutical products. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 18 May 1989 - The Queen v Royal Pharmaceutical Society of Great Britain, ex parte Association of Pharmaceutical Importers and others - Parallel imports - - Trade-mark law - Joined cases 266 and 267/87. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 23 May 1978 - Hoffmann-La Roche & Co. AG v Centrafarm - Case 102/77 - Re-packaging of trade-marked goods. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 9 July 1985 - Pharmon BV v Hoechst AG. - Case 19/84 - Patents - Extent of protection - Exhaustion of patent rights where a compulsory licence has been granted in respect of a parallel patent. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 3 March 1988 - Allen and Hanburys Ltd v Generics (UK) Ltd. - Case 434/85 - Patents endorsed 'Licences of right' - Scope of protection - Compulsory licence under a patent. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 29 November 1983 - Roussel Laboratoria BV - Case 181/82 - Regulation of prices for imported medicines. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 9 June 1988 - Commission of the European Communities v Italian Republic - Case 56/87 - National rules governing the prices of pharmaceutical products. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 19 March 1991 - Commission of the European Communities v Kingdom of Belgium - Case C-249/88 - National legislation on the price of pharmaceutical products - System of programme contracts. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 28 February 1984 - Commission of the European Communities v Federal Republic of Germany - | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court (Fifth Chamber) of 27 May 1986. Société coopérative - Cophalux v Minister for Health - Rules governing the importation and marketing of medicinal products - Joined cases 87 and 88/85 | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment
of the Court (Third Chamber) of 7 March 1989 - Heinz Schumacher v
Hauptzollamt Frankfurt am Main-Ost - Case 215/87 Importation of medicinal preparations |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of March 21, 1991 - against Monteil and Samanni - Case 60/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of 16/04/1991, Upjohn / Farzoo - Case 112/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of May 20, 1992 - Commission / Germany - Case 290/90 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of December 12, 1993 - Pierrel and others / Ministero della Sanità - Case 83/92 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of October 5, 1995 - The Queen / Licensing Authority of the Department of Health and Norgine, ex parte Scotia Pharmaceuticals - Case C-440/93 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (Fifth Chamber) of 3 December 1998 - The Queen v The Licensing Authority established by the Medicines Act 1968 - Case C-368/96 - Marketing authorisation - Abridged procedure - Essentially similar products. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 22 June 1994 - IHT Internationale Heiztechnik GmbH -Case C-9/93 - Splitting of a trade mark as a result of a voluntary assignment - - Free movement of goods. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment
of the Court (Fifth Chamber) of 1 July 1993 - Eurim-Pharm GmbH v
Bundesgesundheitsamt. - Case C-207/91. - Parallel imports of pharmaceutical products |
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 12 November 1996 - The Queen v The Medicines Control Agency - Case C-201/94 - Parallel imports - Direct effect of Directive 65/65/EEC - Marketing authorization. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 11 July 1996 - Eurim-Pharm Arzneimittel GmbH v Beiersdorf AG - Case C-71/94 - Repackaging of trade-marked products | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 11 July 1996 - MPA Pharma GmbH v Rhône-Poulenc Pharma GmbH - Case C-232/94- Repackaging of trade-marked products | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 27 October 1992 - Generics (UK) Ltd and Harris Pharmaceuticals Ltd v Smith Kline & French Laboratories Ltd - Case C-191/90 - Compulsory patent licences | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 5 December 1996 - Merck & Co. Inc. -Joined cases C-267/95 and C-268/95 - Parallel imports of unpatentable pharmaceuticals - Spain and Portugal - | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 9 July 1997 - Generics BV v Smith Kline & French Laboratories Ltd. - Case C-316/95- Patent - Registration of medicinal products - Infringement. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Nicolas Decker v Caisse de maladie des employés privés- Case C-120/95 - Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment
of the Court (Fifth Chamber) of 10 November 1994 - Lucien Ortscheit GmbH
v Eurim-Pharm Arzneimittel GmbH.-Case C-320/93. - Importation of medicines not agreed by the importing State - Prohibition of advertising |
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 8 April 1992 - Commission of the European Communities v Federal Republic of Germany -Case C-62/90 - Importation of medicinal products y private individuals - Limits. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 8 June 1993 - Commission of the European Communities v Kingdom of Belgium - Case C-373/92 - Obligation to carry out examinations which have already been performed in the Member State of origin. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (Sixth Chamber) of 23 January 1997 - Biogen Inc. v Smithkline Beecham Biologicals SA - Supplementary protection certificate for medicinal products - Refusal by the holder of the marketing authorization- Case C-181/95 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (First Chamber) of 15 May 1997 - Bioforce GmbH v Oberfinanzdirektion München - Case C-405/95 - Common customs tariff - Heading 3004 - Echinacea - Medicament. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 20 November 2001 - Zino Davidoff SA v A & G Imports Ltd and Levi Strauss & Co - Exhaustion of the rights conferred by a trade mark - Joined cases C-414/99 to C-416/99 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| EEC Council: Regulation No 17: First Regulation implementing Articles 85 and 86 of the Treaty | http://europa.eu.int/eur-lex/en/lif/dat/1962/en_362R0017.html |
| Regulation No 19/65/EEC of 2 March of the Council on application of Article 85 (3) of the Treaty to certain categories of agreements and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1965/en_365R0019.html |
| Regulation (EEC) No 2821/71 of the Council of 20 December 1971 on application of Article 85 (3) of the Treaty to categories of agreements, decisions and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1971/en_371R2821.html |
| Commission Regulation (EC) No 2790/1999 of 22 December 1999 on the application of Article 81(3) of the Treaty to categories of vertical agreements and concerted practices | http://europa.eu.int/eur-lex/en/lif/dat/1999/en_399R2790.html |
| Commission Regulation (EC) No 2659/2000 of 29 November 2000 on the application of Article 81(3) of the Treaty to categories of research and development agreements (Text with EEA relevance) | http://europa.eu.int/eur-lex/en/lif/dat/2000/en_300R2659.html |
| 76/642/EEC: Commission Decision of 9 June 1976 relating to a proceeding under Article 86 of the Treaty establishing the European Economic Community (IV/29.020 - Vitamins) | http://europa.eu.int/eur-lex/en/lif/dat/1976/en_376D0642.html |
| Community legislation in force on Foodstuffs | http://europa.eu.int/eur-lex/en/lif/reg/en_register_133014.html |
| Community legislation in force on cosmetics | http://europa.eu.int/eur-lex/en/lif/reg/en_register_133016.html |
| Community legislation in force on health protection | http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html |
| European initiatives for smoking prevention | http://europa.eu.int/comm/health/ph/programmes/tobacco/index_en.htm |
| Proposal for a Directive of the European Parliament and of the Council on the approximation of the laws, regulations and administrative provisions of the Member States relating to the advertising and sponsorship of tobacco products - May 30, 2001 | http://europa.eu.int/comm/health/ph/programmes/tobacco/comm283_en.pdf |
| European Union information on the safety of blood | http://europa.eu.int/comm/health/ph/others/safety_blood/index_en.htm |
| The Joint Research Centre - home page - "the European Union’s scientific and technical research laboratory" | http://www.jrc.cec.eu.int/index.asp |
| A European Parliament vote against a ban on human cloning has cleared the way for EU investment in stem cell research over the next five years. | http://europa.eu.int/comm/research/headlines.html#01 |
| Innovation in Europe: Research and Results - Medicine and health | http://europa.eu.int/comm/research/success/en/med/succ-med.html |
| Green
Paper on the Review of Council Regulation (EEC) No 4064/89 (presented by the Commission) - December 11, 2001 - (59 pages) |
http://europa.eu.int/comm/research/success/en/med/succ-med.html |
| Proposal for a Council Regulation amending Regulation No 19/65/EEC on the application of Article 85(3) of the Treaty to certain categories of agreements and concerted practices- September 30, 1998 | http://www.europa.eu.int/comm/competition/antitrust/com1998546_en.pdf |
| Case No COMP/M. 1806 - Astra Zeneca / Novartis - Regulation EEC No 4064/89 - merger procedure - (139 pages) | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1806_en.pdf |
| Merger Procedure Abbott / BASF - Case No COMP/M.2312 -REGULATION (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m2312_en.pdf |
| Merger Procedure Pfizer / Warner Lambert - Case No COMP/M.1878 - Regulation (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1878_en.pdf |
| Merger Procedure - Hoechst / Rhône Poulenc - Case No IV//M. 1378 - Regulation EEC n° 4064/89 (55 pages) | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1378_en.pdf |
| Merger Procedure - Bain / Hoechst-Date Behring - Case No IV/M.954 -Regulation (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m954_en.pdf |
| European Patent Office - Annual Report 2000 - (80 pages) | http://www.european-patent-office.org/epo/an_rep/2000/pdf/fulldoc.pdf |
| Fees under the European Patent Organisation - Rules relating to fees of 20 October 1977 as last amended by decision of the Administrative Council of the European Patent Organisation | http://www.european-patent-office.org/epo/ca/e/28_06_01.htm |
| EPO boards of appeal decisions - monthly update | http://www.european-patent-office.org/dg3/updates/index.htm |
| EPO Enlarged boards of appeal decisions | http://www.european-patent-office.org/dg3/g_dec/index.htm |
| Decision of the Enlarged Board of Appeal regarding the application of Article 53(b) EPC to transgenic plant varieties | http://www.european-patent-office.org/dg3/g_dec/pdf/g980001.pdf |
| Decision of the Enlarged Board of Appeal - December 18, 1992- State of prior art for chemical compositions | http://www.european-patent-office.org/dg3/g_dec/pdf/g920001.pdf |
| Decision of the Enlarged Board of Appeal - EPO - December 5, 1984 - regarding patent on second medical use | http://www.european-patent-office.org/dg3/g_dec/pdf/g830006.pdf |
| EPC - European Patent Convention - (511 pages) | http://www3.european-patent-office.org/dwld/epc/epc_2000.pdf |
| Ancillary Regulations to the European Patent Convention | http://www.european-patent-office.org/legal/anc_reg/e/index.htm |
| Case Law of the Boards of Appeal by themes | http://www.european-patent-office.org/legal/case_law/e/index.htm |
| EPO - Guidelines for examination in the European Patent Office - (466 pages) | http://www.european-patent-office.org/legal/gui_lines/pdf/gui_e_full.pdf |
| International Patent Classification | http://classifications.wipo.int/fulltext/new_ipc/index.htm |
| Introductory Manual to the IPC (International Patent Classification | http://www.wipo.int/classifications/en/index.html |
| WIPO - Patent Protection and Access to HIV / AIDS Phamaceuticals in Sub-Saharan Africa - (105 pages) | http://www.wipo.int/about-ip/en/studies/pdf/iipi_hiv.pdf |
| WHO - Globalization and Access to Drugs - Perspectives on the WTO/TRIPS Agreement (111 pages) | http://www.who.int/medicines/library/dap/who-dap-98-9-rev/who-dap-98-9rev.pdf |
| WHO - Globalization, Patents and Drugs: An Annotated Bibliography - 2001 - (64 pages) | http://www.who.int/medicines/library/par/who-edm-par-2001-1/who-edm-par-2001-1.pdf |
| WHO - Health Reform and Drug Financing: Selected Topics - 1998 - (62 pages) | http://www.who.int/medicines/library/dap/who-dap-98-3/who-dap-98-3.pdf |
| WHO - Global Strategy for Containment of Antimicrobial Resistance - 2001 - (105 pages) | http://www.who.int/emc/amrpdfs/WHO_Global_Strategy_English.pdf |
| WHO - Model list of Essential Drugs - (14 pages) | http://www.who.int/medicines/organization/par/edl/edl11.pdf |
| WHO - The definition and selection process for an EDL (essential drug list) - Technical Briefing Paper - 27 October 2000 | http://www.who.int/medicines/organization/par/edl/infedltechbrief.htm |
| WHO - Herbal medicines - Assessment of safety and efficacy | http://www.who.int/medicines/library/trm/medicinalplants/assessdocs.shtml |
| WHO - Acupuncture | http://www.who.int/medicines/library/trm/acupuncture/acupdocs.shtml |
| WHO - Biotechnology and Food Safety - Report of a Joint FAO/WHO Consultation | http://www.fao.org/WAICENT/faoinfo/economic/esn/biotech/tabconts.htm |
| Codex Alimentarius Commission - home page | http://www.codexalimentarius.net/ |
| WHO - Model Certificate of a Pharmaceutical Product | http://www.who.int/medicines/organization/qsm/activities/drugregul/certification/modcert.html |
| WHO - Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce | http://www.who.int/medicines/organization/qsm/activities/drugregul/certification/certifguide.html |
| WHO - Achieving balance in national opioids control policy -- Guidelines for assessment - 2000 - (45 pages) | http://www.who.int/medicines/library/qsm/who-edm-qsm-2000-4/Balance%20in%20Nat%20Opioids%20Control%20Policy%20final.pdf |
| International Narcotics Control Board - home page | http://www.incb.org/ |
| WHO - Good Manufacturing Practices | http://www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html |
| International Conference on Harmonisation - ICH - home page | http://www.ifpma.org/ich1.html |
| ICH - Harmonisation process | http://www.ifpma.org/ich4.html |
| ICH - list of guidelines | http://www.ifpma.org/ich5.html |
| WTO - Uruguay Round Final Act: full texts | http://www.wto.org/english/docs_e/legal_e/final_e.htm |
| WTO - Council for Trade-Related Aspects of Intellectual Property Rights - Document prepared by the International Bureau of WIPO for the Meeting on Intellectual on Genetic Resources - An Overview | http://docsonline.wto.org/_ |
| WTO - THE RELATIONSHIP BETWEEN THE CONVENTION ON BIOLOGICAL DIVERSITY (CBD) AND THE AGREEMENT ON THE TRADE-RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS (TRIPS); | http://docsonline.wto.org/_ |
| Convention unique sur les stupéfiants de 1961 - conclue à New York le 30 mars 1961 - Signée par la Suisse le 20 avril 1961 - RS 0.812.121.0 | http://www.admin.ch/ch/f/rs/i8/0.812.121.0.fr.pdf |
| Protocole portant amendement de la Convention unique sur les stupéfiants de 1961 - Conclu à Genève le 25 mars 1972 - Approuvé par l’Assemblée fédérale le 21 mars 1995 - RS 0.812.121.01 | http://www.admin.ch/ch/f/rs/i8/0.812.121.01.fr.pdf |
| Convention sur les substances psychotropes - Conclue à Vienne le 21 février 1971 - Entrée en vigueur pour la Suisse le 21 juillet 1996 - RS 0.812.121.02 | http://www.admin.ch/ch/f/rs/i8/0.812.121.02.fr.pdf |
| Convention internationale de l’opium - Conclue à La Haye le 23 janvier 1912 -Entrée en vigueur pour la Suisse le 15 janvier 1925 - RS 0.812.121.2 | http://www.admin.ch/ch/f/rs/i8/0.812.121.2.fr.pdf |
| Protocole amendant les accords, conventions et protocoles sur les stupéfiants - Entré en vigueur pour la Suisse le 25 septembre 1947 - RS 0.812.121.21 | http://www.admin.ch/ch/f/rs/i8/0.812.121.21.fr.pdf |
| Protocole visant limiter et à réglementer la culture du pavot, ainsi que la production, le commerce international, le commerce de gros et l’emploi de l’opium - conclu à New York le 23 juin 1953 - RS 0.812.121.3 | http://www.admin.ch/ch/f/rs/i8/0.812.121.3.fr.pdf |
| Convention internationale relative stupéfiants - conclue à Genève le 19 février 1925 - entrée en vigueur pour la Suisse le 2 juillet 1929 - RS 0.812.121.4 | http://www.admin.ch/ch/f/rs/i8/0.812.121.4.fr.pdf |
| Convention pour limiter la fabrication et réglementer la distribution des stupéfiants - conclue à Genève le 13 juillet 1931 - entrée en vigueur pour la Suisse le 9 juillet 1933 - RS 0.812.121.5 | http://www.admin.ch/ch/f/rs/i8/0.812.121.5.fr.pdf |
| Protocole du 19 novembre 1948 plaçant sous contrôle international certaines drogues non visées par la Convention du 13 juillet 1931 - entré en vigueur pour la Suisse le 18 mars 1953 - RS 0.812.121.52 | http://www.admin.ch/ch/f/rs/i8/0.812.121.52.fr.pdf |
| Convention du 26 juin 1936 pour la répression du trafic illicite des drogues nuisibles - conclue à Genève, le 26 juin 1936 - entrée en vigueur pour la Suisse le 31 mars 1953 - RS 0.812.121.6 | http://www.admin.ch/ch/f/rs/i8/0.812.121.6.fr.pdf |
| Convention contre le dopage - conclue à Strasbourg le 16 novembre 1989 - entrée en vigueur pour la Suisse le 1er janvier 1993 - RS 0.812.122.1 | http://www.admin.ch/ch/f/rs/i8/0.812.122.1.fr.pdf |
| Accord européen relatif à l’échange de substances thérapeutiques d’origine humaine - conclu à Paris le 15 décembre 1958 - entré en vigueur pour la Suisse le 1er décembre 1965 - RS 0.812.161 | http://www.admin.ch/ch/f/rs/i8/0.812.161.fr.pdf |
| Convention relative à l’élaboration d’une Pharmacopée Européenne - conclue à Strasbourg le 22 juillet 1964 - entrée en vigueur pour la Suisse le 8 mai 19742 - RS 0.812.21 | http://www.admin.ch/ch/f/rs/i8/0.812.21.fr.pdf |
| United States Department of Agriculture (USDA) - Agricultural Biotechnology | http://www.aphis.usda.gov/biotechnology/index.html |
| U.S. Environmental Protection Agency - EPA - home page | http://www.epa.gov/ |
| National Academy of Sciences - Transgenic Plants and World Agriculture - (46 pages) | http://bob.nap.edu/html/transgenic/pdf/transgenic.pdf |
| OECD - Biotechnology and Food Safety - home page | http://www1.oecd.org/subject/biotech/ |
| OECD .- Ad Hoc Group on Food Safety - Overview of National Food Safety Systems and Activities - (12 pages) | http://www1.oecd.org/subject/biotech/overview_nfssa.pdf |
| OECD - GM Food Safety : Facts, Uncertainties and Assessment - February March 2000 - Raporteur's summary - (11 pages) | http://www1.oecd.org/subject/biotech/Rapporteureng.pdf |
| OECD - Working Party on Biotechnology - Health Policy Brief - Data Protection in Transborder Flows of Health Research Data - December 1999 - (33 pages) | http://www.olis.oecd.org/olis/1999doc.nsf/8358a613ec4462afc12569fa005d1700/c9c84852a946479cc12568430057171b/$FILE/12E93887.ENG |
| OECD - The Economic Aspects of Biotechnologies related to Human Health Part I - 1998 - (72 pages) | http://www1.oecd.org/dsti/sti/s_t/biotech/prod/health.pdf |
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| OECD - Food Safety and Quality -1999 - (82 pages) | http://www1.oecd.org/subject/biotech/5199081e.pdf |
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| OECD - home page | http://www.oecd.org |
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| OECD - Why Mice Matter: Novel Systems for the Study of Human Disease from Basic Research to Applications - 1998 - (68 pages) | http://www.oecd.org/pdf/M000014000/M00014633.pdf |
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| OECD - Patents and Innovation in the International Context - 1997 - (36 pages) | http://www.oecd.org/pdf/M000014000/M00014675.pdf |
| OECD - The Evaluation of Scientific Research: Selected Experiences - 1997 - (112 pages) | http://www.oecd.org/pdf/M000014000/M00014831.pdf |
| OECD - Fiscal Measures to Promote R&D and Innovation - 1996 - (94 pages) | http://www.oecd.org/pdf/M000014000/M00014678.pdf |
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| Council of Europe - CDBI - Projet de Protocole additionnel à la Convention sur les droits de l'Homme et la Biomédecine relatif à la transplantation d'organes et de tissus d'origine humaine et rapport explicatif - February 1999 - (30 pages) | http://www.nfp46.ch/downloads/law/ceprottp99.pdf |
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| Council
of Europe - Projet de Protocole additionnel à la Convention sur les
Droits de l'Homme et la Biomédecine, relatif à la transplantation d'organes et de tissus d'origine humaine - (9 pages) |
http://www.bag.admin.ch/transpla/inter/f/Draft_PROTOCOL_TRANSP_250701.pdf |
| Decision of the Swiss Federal Tribunal - December 10, 2001 - case n° K.81/98 - I. Kammer - regarding sickness insurance reimbursement | http://www.bger.ch |
| WTO - CANADA – TERM OF PATENT PROTECTION - Arbitration under Article 21.3(c) of the Understanding on Rules and Procedures Governing the Settlement of Disputes - (19 pages) | http://www.wto.org/english/tratop_e/dispu_e/170arb_e.pdf |
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| WTO
- Canada – Patent Protection of Pharmaceutical products - Complaint by
the European Communities and their member States Report of the panel - (March 2000) - (222 pages) |
http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf |
| WTO - Canada – Term of Patent Protection - Report of the Panel - May 2000 - (163 pages in two parts) | http://www.wto.org/english/tratop_e/dispu_e/1391da.pdf http://www.wto.org/english/tratop_e/dispu_e/1391db.pdf |
| La situation en droit des cartels - Rapport à l’attention de la Commission de gestion du Conseil national - October 11, 2000 - (62 pages) | http://www.admin.ch/ch/f/ff/2001/3191.pdf |
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| René Rhinow - Gutachten über die Verfassungsmässigkeit der Einführung von direkten Sanktionen im Kartellgesetz zuhanden des Generalsekretariats des Eidgenössischen Volkswirtschaftsdepartements (EVD) - (44 pages) | http://www.evd.admin.ch/dynamic/dm/LOI_SUR_LES_CARTELS/F/INTRODUCTION/Gutachten%20Kartellgesetzrevision_.pdf |
| OFEFP - Dissémination expérimentale de blé génétiquement modifié à Lindau (ZH) - Evaluation de l’essai à l’aide d’une grille de décision1 | http://www.umwelt-schweiz.ch/imperia/md/content/buwalcontent/folder/01-11-20gentech/13.pdf |
| Verfügung
- November 20, 2001 - betreffend das Gesuch der ETH Zürich, vertreten
durch das Institut für Pflanzenwissenschaften, vom 04. Januar 2001 um Bewilligung eines Freisetzungsversuchs mit gentechnisch verändertem KP4-Weizen in Lindau (ZH). |
http://www.umwelt-schweiz.ch/imperia/md/content/buwalcontent/folder/01-11-20gentech/9.pdf |
| Swiss Federal Veterinary Office - home page | http://www.bvet.admin.ch/0_navigation-e/0_index-intern.html |
| The ARAMIS Information System for research and development projects in Switzerland - home page - "provide information to interested parties about research which is financed or carried out by the Federal Government" | http://www.aramis-research.ch/e/index.html |
| Swiss Federal Office for Education and Science - home page | http://www.admin.ch/bbw/ |
| WTO, United States - Section 211 Omnibus Appropriations Act of 1998 - AB-2001-7 - Report of the Appellate Body | http://docsonline.wto.org/DDFDocuments/t/wt/ds/176ABR.doc |
| U.S. Code of Federal Regulations CFR - Title 45 - Public Welfare - Part 46 - Protection of human subjects | http://www.brown.edu/Administration/Research_Administration/OPRR/46index.html |
| Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research - April 18, 1979 | http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm |
| Jeanne Clark et al., USPTO - Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? - December 2000 - (17 pages) | http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf |
| GAO Report - Prescription Drugs: Prices Available Through Discount Cards and From Other Sources - December 5, 2001 - (10 pages) | http://www.gao.gov/new.items/d02280r.pdf |
| Center for Disease Control and Prevention - home page | http://www.cdc.gov/ |
| U.S. Surgeon General - home page | http://www.surgeongeneral.gov/sgoffice.htm |
| U.S. Public Health Service, Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda. Washington, DC: Department of Health and Human Services, 2000 - (57 pages) | http://www.surgeongeneral.gov/cmh/cmhreport.pdf |
| U.S. Department of Health and Human Services. The Surgeon General’s call to action to prevent and decrease overweight and obesity - 2001 - (39 pages) | http://www.surgeongeneral.gov/topics/obesity/calltoaction/CalltoAction.pdf |
| Treating Tobacco Use and Dependence, U.S. Department of Health and Human Services Public Health Service - June 2000 - (196 pages) | http://www.surgeongeneral.gov/tobacco/treating_tobacco_use.pdf |
| U.S. Department of Health and Human Services. Reducing Tobacco Use: A Report of the Surgeon General. Atlanta, Georgia: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention - 2000 - (474 pages) | http://www.cdc.gov/tobacco/sgr/sgr_2000/FullReport.pdf |
| KPMG - translation of the Swiss law on cartels | http://www.kpmg.ch/library/attachments/tbasic/Federal_Law_Cartels_SR251_0_2283528.pdf |
| Expert Panel on the Future of Food Biotechnology - Elements of Precaution: Recommendations for the Regulation of Food Biotechnology in Canada - February 2001 - (261 pages) | http://www.rsc.ca/foodbiotechnology/GMreportEN.pdf |
| Royal Commission on Genetic Modifications - the Report - New Zealand | http://www.gmcommission.govt.nz/RCGM/rcgm_report.html |
| US Congress - The Best Pharmaceuticals for Children Act | http://www.fda.gov/cder/pediatric/PL107-109.pdf |
| FDA- International Conference on Harmonization - Public Meeting - Transcripts - 10:30 a.m.- Thursday, January 17, 2002 | http://www.fda.gov/cder/audiences/iact/meeting_transcript_011702.htm |
| GAO - Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest - November 2001 - (46 pages) | http://www.gao.gov/new.items/d0289.pdf |
| FDA News - home page - "premier provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the" FDA | http://www.fdanews.com/index.html |
| Office fédéral des assurances sociales - Analyse des effects de l’assurance-maladie Rapport de synthèse - December 2001 - (181 pages) | http://www.bsv.admin.ch/aktuell/presse/2001/f/01121701_synthesebericht.pdf |
| OFAS - Information relative au nouveau système de formation des prix des médicaments - (6 pages) | http://www.bsv.admin.ch/kv/aktuell/f/f_InfoMedi1.pdf |
| OFAS - Statistique de l’assurance-maladie 2000 - 2001 - (138 pages) | http://www.bsv.admin.ch/statistik/details/f/kv00f.pdf |
| OFAS - Liste des Spécialités | http://www.bsv.admin.ch/sl/liste/f/index.htm |
| The Swiss Conference of the Cantonal Ministers of Public Health - home page - "serves as a political coordination organ for the health ministers of the twenty-six cantons" | http://www.sdk-cds.ch/en/praesentation-e.html |
| Communication from the European Communities and their Member States to the TRIPS Council - The Relationship Between the Provisions of the TRIPS Agreement and Access to Medicines - Brussels, 13 June 2001 - (5 pages) | http://europa.eu.int/comm/trade/pdf/med_trips.pdf |
| The European Commission - DG Trade - Access to Medicines - Home page | http://europa.eu.int/comm/trade/csc/med.htm |
| Compulsory Licensing under TRIPs and Data Exclusivity - (24 pages) | http://europa.eu.int/comm/trade/pdf/med_lic.pdf |
| United Nations Economic Commission for Africa - Organization of African Unity - Africa and the Multilateral Trading System Doha and Beyond - An Issues Paper - (32 pages) | http://www.uneca.org/eca_resources/Conference_Reports_and_Other_Documents/espd/2001/eca_oau/issue_paper.PDF |
| WIPO - Agenda for Development of the International Patent System - (15 pages) | http://www.wipo.int/eng/document/govbody/wo_gb_ab/pdf/a36_14.pdf |
| CRS Issue Brief for Congress - Technology Transfer: Use of Federally Funded Research and Development -Congressional Research Service The Library of Congress- February 2002 - (18 page) | http://www.cnie.org/nle/crsreports/science/st-9.pdf |
| World Bank - Global Prospects and the Developing Countries 2002 - (271 pages) | http://www.worldbank.org/prospects/gep2002/gep2002complete.pdf |
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| Moore v. Regents of the University of California - 793 P.2d 479 (Cal. 1990) | http://www.richmond.edu/~wolf/moore.htm |
| Diamond v. Chakrabarty, 447 U.S. 303 (1980) | http://www.ipmall.fplc.edu/hosted_resources/jepson/unit3abcd/diamond2.htm |
| Rapport annuel 2001 de la Commission de la concurrence au Conseil fédéral selon l'art. 49 al. 2 Lcart - February 2002 - (20 pages) | http://www.wettbewerbskommission.ch/site/f/medien/Medienmitteilungen.Par.0027.Pic3.pdf |
| ComCo - Droit et politique de la concurrence DPC 98/1 - (195 pages) | http://www.wettbewerbskommission.ch/site/f/dpc/dpc.Par.0002.Pic0.pdf |
| ComCo - Droit et Politique de la Concurrence 98/2 - (192 pages) | http://www.wettbewerbskommission.ch/site/f/dpc/dpc.Par.0002.Pic1.pdf |
| ComCo - Droit et Politique de la Concurrence 98/4 - (56 pages) | http://www.wettbewerbskommission.ch/site/f/dpc/dpc.Par.0002.Pic3.pdf |
| ComCo - Droit et Politique de la Concurrence (DPC) 99/1 - (211 pages) | http://www.wettbewerbskommission.ch/site/f/dpc/dpc.Par.0003.Pic0.pdf |
| Peter
Drahos -Developing Countries and International Intellectual Property
Standard-setting - Commission on Intellectual Property Rights Study Paper 8 -February 2002 - (52 pages) |
http://www.iprcommission.org/documents%5CDrahos%20study.pdf |
| Michael Blakeney - Access to Genetic Resources, Gene-based Inventions and Agriculture - Commission on Intellectual Property Rights - Study Paper 3b - February 2002 - (39 pages) | http://www.iprcommission.org/documents%5CBlakeney%20study.pdf |
| CIPR - Commission on Intellectual Property Rights - home page - "The Commission has been set up by the British government to look at how intellectual property rights can work better for poor people and developing countries" | http://www.iprcommission.org/index.asp |
| Rapport annuel du Surveillant des prix - 2001 - February 2002 - (52 pages) | http://www.monsieur-prix.admin.ch/dynamic/rapport/01_JB/F/Microsoft%20Word%20-%20rapport%20annuel%202001.pdf |
| Swiss National Council - Session d'hiver 2000 - Quatrième séance - November 30, 2000 - Debate on the Law on Therapeutic Products | http://www.parlament.ch/ab/frameset/d/n/4605/22311/d_n_4605_22311_22324.htm?DisplayTextOid=22325 |
| Swiss Senate - Session d'hiver 2000 - Huitième séance - December 7, 2000 - Debate on the Law on Therapeutic Products | http://www.parlament.ch/ab/frameset/d/s/4605/23400/d_s_4605_23400_23404.htm?DisplayTextOid=23405 |
| Senate and National Council, Winter session, 13th session of Winter 2000, December 15, 2000 - Final vote | http://www.parlament.ch/ab/frameset/d/s/4605/25104/d_s_4605_25104_25111.htm?DisplayTextOid=25112 |
| Procédure de consultation relative aux ordonnances d’application afférentes à la loi sur les produits thérapeutiques (LPT) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/orien.pdf |
| List of disagreement between the Swiss Senate and the Swiss National Council, | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/diff.pdf |
| Draft - Ordonnance sur les médicaments (ordonnance sur les médicaments, OMéd) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vam.pdf |
| Rapport explicatif concernant l’ordonnance sur les médicaments OMéd - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vam_erl.pdf |
| Draft
- Ordonnance de l'ISPT sur les exigences relatives à l'autorisation de
mise sur le marché des médicaments (ordonnance sur les exigences relatives aux médicaments, OEMéd) |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/amzv.pdf |
| Draft - Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ambv.pdf |
| Rapport explicatif concernant l’ordonnance sur les autorisations dans le domaine des médicaments - OAMéd - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ambv_erl.pdf |
| Draft - Ordonnance sur les dispositifs médicaux - Odim | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv.pdf |
| U.S. National Institutes of Health (NIH), about NIH | http://www.nih.gov/about/ |
| FDA, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update | http://www.fda.gov/oc/ohrt/irbs/default.htm |
| U.S. Department of Health and Human Services (HHS), home page | http://www.hhs.gov/ |
| NIH, List of bioethics resources on the web | http://www.nih.gov/sigs/bioethics/international.html |
| OTA, Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues, September 1995, OTA-BP-H-163 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9524/9524.PDF |
| Swiss National Council - Session de printemps 2000 - Sixième séance - 99.020, débat sur la Loi sur les produits thérapeutiques | http://www.parlament.ch/ab/frameset/d/n/4602/9085/d_n_4602_9085_9204.htm |
| Swiss National Council - Session de printemps 2000 - Troisième séance - 08.03.00-08h35, Debate on the Law on Therapeutic products | http://www.parlament.ch/ab/frameset/d/n/4602/8187/d_n_4602_8187_8363.htm |
| Swiss National Council - Session de printemps 2000 - Quatrième séance - 08.03.00-15h00, debate on the Law on Therapeutic products. | http://www.parlament.ch/ab/frameset/d/n/4602/8533/d_n_4602_8533_8534.htm |
| Swiss Senate - Session d'automne 2000 - Septième séance - September 27, 2000 - Debate on the Law on Therapeutic products, | http://www.parlament.ch/ab/frameset/d/s/4604/18863/d_s_4604_18863_18877.htm?DisplayTextOid=18878 |
| Rapport explicatif concernant l’ordonnance sur les dispositifs médicaux - Odim - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv_erl.pdf |
| Draft - Ordonnance sur les émoluments de l’Institut suisse des produits thérapeutiques - OE ISPT | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/shi_gebv.pdf |
| Rapport
explicatif concernant l’ordonnance sur les émoluments de l’Institut
suisse des produits thérapeutiques - OE ISPT - Project of September 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/shi_gebv_erl.pdf |
| Procédure de consultation - Projets d’ordonnances sur les produits thérapeutiques (seconde tranche) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/eroeffnung.pdf |
| Procédure de consultation sur les projets d’ordonnances sur les produits thérapeutiques: Nouvelle numérotation des articles de la loi sur les produits thérapeutiques: adaptation des renvois dans les ordonnances de la première tranche | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/artnum.pdf |
| Draft - Modification de l’ordonnance sur les médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ergaenzungamv.pdf |
| Rapport explicatif concernant la modification de l’ordonnance sur les médicaments - OMéd - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ergaenzungamv_erl.pdf |
| Draft
- Ordonnance sur l’abrogation et la modification du droit en vigueur
du fait de la loi sur les produits thérapeutiques§ |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vaend.pdf |
| Rapport
explicatif concernant l’ordonnance sur l’abrogation et la
modification du droit en vigueur du fait de la loi sur les produits thérapeutiques - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vaend_erl.pdf |
| Draft - Ordonnance sur la publicité pour les médicaments - OPMéd - | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vawerb.pdf |
| Rapport
explicatif concernant l’ordonnance du Conseil fédéral sur la
publicité pour les médicaments Ordonnance sur la publicité pour les médicaments - OPMéd - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vawerb_erl.pdf |
| Draft - Ordonnance de l’Institut suisse des produits thérapeutiques sur l’autorisation simplifiée de médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza.pdf |
| Rapport
explicatif concernant l’ordonnance de l’Institut suisse des produits
thérapeutiques sur l’autorisation simplifiée de médicaments - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza_erl.pdf |
| Draft - Ordonnance de l’Institut suisse des produits thérapeutiques sur la mise sur le marché des médicaments homéopathiques et des médicaments anthroposophiques sans indications | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vhom.pdf |
| Rapport
explicatif concernant l’ordonnance de l’Institut suisse des produits
thérapeutiques sur la mise sur le marché des médicaments homéopathiques et des médicaments anthroposophiques sans indications - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vhom_erl.pdf |
| Draft - Ordonnance sur les inspections dans le domaine des médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp.pdf |
| Rapport explicatif concernant l’ordonnance sur les inspections dans le domaine des médicaments - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp_erl.pdf |
| Draft - Ordonnance sur les essais cliniques de produits thérapeutiques | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vklinver.pdf |
| Rapport explicatif concernant l’ordonnance sur les essais cliniques de médicaments - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vklinver_erl.pdf |
| Rapport
explicatif concernant le projet de modification de - l’ordonnance du
29 mai 1996 sur les stupéfiants et les substances psychotropes - Ostup - et de l' ordonnance sur les précurseurs - Opréc |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendbetm_erl.pdf |
| Draft -Ordonnance sur les stupéfiants et les substances psychotropes | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendbetm.pdf |
| Draft - Ordonnance sur les précurseurs et autres produits chimiques utilisés pour la fabrication des stupéfiants et de substances psychotropes | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendvorlv.pdf |
| FDA - Mifepristone Information (home page) | http://www.fda.gov/cder/drug/infopage/mifepristone/ |
| FDA, CDER, New and Generic Drug Approvals: 1998-2001 | http://www.fda.gov/cder/approval/index.htm |
| FDA, Electronic Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations (query page) | http://www.fda.gov/cder/ob/default.htm |
| United States Patent and Trademark Office - US. PTO | http://www.uspto.gov/ |
| FDA, Warning Letters (home page) | http://www.fda.gov/foi/warning.htm |
| The United States General Accounting Office - home page | http://www.gao.gov/ |
| European Patent Office - Guidelines for examination (400 pages) | http://www.european-patent-office.org/legal/gui_lines/pdf/gui_e_full.pdf |
| Swiss Federal Institute of Intellectual Property - home page (in English) | http://www.ige.ch/E/gisi.htm |
| Council for International Organizations of Medical Science ("CIOMS is an international, nongovernmental, non-profit-making organization established jointly by WHO and UNESCO in 1949.") | http://www.cioms.ch/ |
| World Trade Organization - home page | http://www.wto.org/ |
| Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme | http://www.picscheme.org/index.htm |
| Complaint of the State of Montana v. Abbott - February 2002 - (45 pages) | http://www.doj.state.mt.us/ago/newsrel/02releases/BSCComplaint.pdf |
| Complaint of the State of Nevada v. Abbott - January 2002 - (40 pages) | http://ag.state.nv.us/agpress/2002/02_0117a.pdf |
| Agency for Healthcare Research and Quality (AHRQ) - home page | http://www.ahcpr.gov/ |
| Office of Inspector General (OIG) - Review of Pharmacy Acquisition Costs for Drugs Reimbursed Under the Medicaid Prescription Drug Program of the Montana Department of Public Health and Human Services - February 7, 2002 - (20 pages) | http://oig.hhs.gov/oas/reports/region6/60100005.pdf |
| Speech of Thomas B. Leary - FTC - Antitrust Issues in the Settlement of Pharmaceutical Patent Disputes, Part II | http://www.ftc.gov/speeches/leary/learypharmaceuticalsettlement.htm http://www.ftc.gov/speeches/leary/learypharma.htm |
| Complaint of the FTC Schering-Plough Corporation v. and American Home Products Corporation, | http://www.ftc.gov/os/2001/04/scheringpart3cmp.pdf |
| FTC -Generic Drug Competition: Request for Public Comment on Proposed Commission Information Request to Firms In the Pharmaceutical Industry. - Agency Information Collection Activities; Proposed Collection; Comment Request - Federal Register Notice | http://www.ftc.gov/os/2000/10/frngenericdrugstudy.htm |
| CBO - How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry - July 1998 | http://www.cbo.gov/showdoc.cfm?index=655&sequence=0&from=1 |
| FTC - Memorandum of law - of Amicus Curiae - in opposition to defendant's motion to dismiss -In re: Buspirone Patent Litigation - In re: Buspirone Antitrust Litigation - (37 pages) | http://www.ftc.gov/os/2002/01/busparbrief.pdf |
Last updated: July 7, 2002