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 |
| Commission de gestion du Conseil des Etats - Rapport - Requête à l’autorité de surveillance des cantons concernant la jurisprudence du Conseil fédéral en matière de recours contre les décisions tarifaires des gouvernements cantonaux April 2002 - 28 p | http://www.parlament.ch/F/Veroeffentlichungen/Kommissionsberichte/KVGTarife_GPK_S_f.pdf |
| 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 |
| Swissmedic - Guide to the regulation of medical devices | http://www.swissmedic.ch/md/files/leitf-e.html |
| Swissmedic - Checkliste documents pour essais cliniques de thérapie génique/ OGM | http://www.swissmedic.ch/files/pdf/B3.1.83_Checkliste_documents_essais_cliniques_th%E9rapie_g%E9nique_OGM.doc http://www.swissmedic.ch/files/pdf/B3.1.82_Requ%EAte_autorisation_essais_cliniques_th%E9rapie_g%E9nique_OGM.dot |
| Swiss Ethics Committee on Non-human Gene Technology - Avis relatif à la concrétisation de la notion de dignité de la créature dans le cadre du projet de révision de la loi sur la protection des animaux - (11 pages) | http://www.buwal.ch/stobobio/ekah/pdf/171199f.pdf http://www.buwal.ch/stobobio/ekah/pdf/tier_f.pdf |
| 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 |
| Protection de la propriété intellectuelle dans le domaine de la biotechnologie: considérations éthiques concernant la brevetabilité des animaux et des plantes Une contribution à la discussion - (15 pages) | http://www.buwal.ch/stobobio/ekah/pdf/diskussion_f.pdf |
| 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 |
| Swiss Federal Act on Animal Protection of March 9, 1978 (State as per July 1, 1995) | http://www.bvet.admin.ch/tierschutz/e/gesetzgebung/tschg_tschv_version_2001.pdf |
| 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 |
| 3 Warning Letters on Good Laboratory Practices | http://www.fda.gov/foi/warning_letters/g1990d.pdf http://www.fda.gov/foi/warning_letters/g1864d.pdf http://www.fda.gov/foi/warning_letters/g2044d.pdf |
| 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
de la loi sur la protection des animaux Rapport explicatif de l'avant-projet - September 2001 - (23 pages) |
http://www.bvet.admin.ch/info-service/f/vernehmlassungen/010921tschg_erl.pdf |
| 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 initiat |