Governments

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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