All Therapeutic Products
| Title | Link |
|---|---|
| Ip-health -- Discussions of Intellectual Property and Health Care | http://lists.essential.org/mailman/listinfo/ip-health |
| The New England Journal of Medicine - registration for full text of Original and Special Articles six months after publication and to receive the Table of Contents by e-mail. | https://secure.mms.org/custserv/single_signin.asp?productcode=toc |
| FDA - CDER - subscribe to mailing lists free of charge. | http://www.fda.gov/cder/cdernew/listserv.html |
| AMNews e-mail alert service - offers our online readers free e-mail notification of each week's content as it is posted to our Web site. | http://www.ama-assn.org/public/journals/amnews/amnalert.htm |
| E-Mail Alert Service - "JAMA and Archives Journals offer free tables of contents from JAMA, the Archives Journals, and news listings from American Medical News via e-mail" | http://www.ama-assn.org/public/journals/tocalert.htm |
| The Scientist - "Registration is required to view our online articles. Registration is FREE" | http://www.the-scientist.com/register.htm |
| Annals of Internal Medicine - "Sign up below and we will e-mail you the Table of Contents for each issue on the day of publication" | http://www.annals.org/shared/ealert_regtoc.html |
| Public Citizen - The Health Research Group - "Keep up with Public Citizen through your E-mail!" | http://www.citizen.org/hrg/ |
| Kaisernetwork.org - E-mail alert | http://www.kaisernetwork.org/email_alert/email.cfm |
| The Economics of TB Drug Development - Global Alliance for TB Drug Development - October 2001 - (168 pages) | http://www.tballiance.org/3_per.cfm?rm=economics&sub=per |
| 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 |
| Kurt R. Karst - Comments Pediatric Testing of Prescription Drugs: the Food and Drug Administration's Carrot and Stick for the Pharmaceutical Industry - American University Law Review Vol. 49:739 - 2000 - (34 pages) | http://www.wcl.american.edu/journal/lawrev/49/karst.pdf |
| Public Citizen - Patently Offensive Congress Set to Extend Monopoly Patents for Cipro and Other Drugs - November 2001 - (20 pages) | http://www.citizen.org/documents/ACF34F.PDF |
| Pediatric Trials and Intellectual Property Incentives in the EU - A Report by Europe Economics for Merck Sharp and Dohme (Europe) Inc. - May 2001 - (73 pages) | http://www.eer.co.uk/download/eepaedia.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 |
| Marie Abbet - Cobayes Humains - L'insoutenable légèreté de nos autorités - l'Hebdo - 3 juin 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_22/cobaye_22.html |
| Béatrice Schaad - Cobayes Humains - La Suisse importe des cobayes humains - l'Hebdo - 12 mai 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_20/dossier_intro_20.html |
| Marie Abbet - Cobayes Humains - La chimie bâloise paiera-t-elle le prix de la honte? - L'Hebdo - 1er juillet 1999 | http://www.webdo.ch/hebdo/hebdo_1999/hebdo_26/cobayes_26.html |
| 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 |
| Jean-Louis Duc, Professeur UNIL - Quelques réflexions en rapport avec la dispensation des médicaments à la lumière de l'exemple vaudois - (21 pages) | http://www.unil.ch/droit/publ_jld/Medicaments.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 |
| AMEX Pharmaceutical Index | http://www.amex.com/asp/option_chain.asp?symbol=DRG&selected=DRG |
| RxList - The Top 200 Prescriptions* for 2000 by Number of US Prescriptions Dispensed Generic name link leads to Drug Monograph information where available. | http://www.rxlist.com/top200.htm |
| Pfizer SEC filings with SEC | http://www.edgar-online.com/brand/yahoo/search/?sym=PFE |
| 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 |
| IHGT -Insitute for Human Gene Therapy - University of Pennsylvania - More information on OTC Deficiency and the Clinical Trial | http://www.uphs.upenn.edu/ihgt/otcinfo.html |
| Association of American Medical Colleges - Protecting Subjects, Preserving Trust, Promoting Progress– Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research - December 2001 - (25 pages) | http://www.aamc.org/members/coitf/firstreport.pdf |
| Report of Independent Panel Reviewing the University of Pennsylvania's Institute for Human Gene Therapy | http://www.upenn.edu/almanac/v46/n34/IHGT-review.html |
| Action by the University of Pennsylvania in Response to the "Report of the Independent Panel Reviewing the Institute for Human Gene Therapy" | http://www.upenn.edu/almanac/v46/n34/OR-IHGT-actions.html |
| 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 |
| University of Pennsylvania - ORA web site home page - regulatory affairs | http://www.upenn.edu/regulatoryaffairs/ |
| 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 |
| Philippe Ducor - Coauthorship and Coinventorship - Science Magazine - Volume 289, Number 5481, Issue of 11 Aug 2000, pp. 873-875. | http://watson.fapesp.br/nuplitec/873.html |
| Uniform Requirements for Manuscripts Submitted to Biomedical Journals - Updated May 1999 | http://www.acponline.org/journals/annals/01jan97/unifreqr.htm |
| Biotechnology, Ethics and Government: Report to the Interdepartmental Working Group on Ethics - Winter 1998 - (125 pages) | http://strategis.ic.gc.ca/pics/bh/bioteche.pdf |
| Anna E. Morrison - The U.S. PTO's New Utility Guidelines: Will They Be Enough to Secure Gene Patent Rights? - 1 J. MARSHALL REV. INTELL. PROP. L. 142 - 2001 - (22 pages) | http://www.jmls.edu/ripl/vol1/issue1/morrison.pdf |
| Lawrence M. Sung - Part II: Judicial Issues Stranger In A Strange Land: Biotechnology and the Federal Circuit - 168 Re-Engineering Patent Law Vol. 2:167- (32 pages) | http://law.wustl.edu/Journal/2/p167sung.pdf |
| Sherry M. Knowles - Written Description and Enablement Requirements for Pharmaceutical, Chemical and Biotechnology Inventions - (36 pages) | http://www.kslaw.com/library/pdf/pharmaknowles.pdf |
| Matthew D. Kellam - Making Sense out of Antisense: The Enablement Requirement in Biotechnology After Enzo Biochem v. Calgene - 222 INDIANA LAW JOURNAL [Vol. 76:221 - (22 pages) | http://www.law.indiana.edu/ilj/v76/no1/kellam.pdf |
| Carlos Correa- Integrating Public Health Concerns into Patent Legislation in Developing Countries - South Centre - 2000 (143 pages) | http://www.southcentre.org/publications/publichealth/publichealth.pdf |
| Arti Kaur Rai - Regulating Scientific Research: Intellectual Property Rights and the Norms of Science - Nortwestern University Law Review - 1999 - (76 pages) | http://www.acusd.edu/~arai/raifinal.pdf |
| DeAngelis CD. Conflict of interest and the public trust. JAMA. 2000;284:2237-2238 | http://jama.ama-assn.org/issues/v284n17/fpdf/jed00080.pdf |
| 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 |
| Mattias Ganslandt and Keith E. Maskus - Parallel Imports of Pharmaceutical Products in the European Union - Please do not quote without permission - (27 pages) | http://econ.worldbank.org/files/2240_wps2630.pdf |
| Mattias Ganslandt and Keith E. Maskus - Parallel Imports of Pharmaceutical Products in the European Union - The Research Institute of Industrial Economics - Working Paper No. 546, 2001 - (28 pages) | http://swopec.hhs.se/iuiwop/papers/iuiwop0546.pdf |
| 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 |
| Leu Investment Research - Sector Report: Pharmaceuticals Europe – Hopes Focus on Biotechnology - December 2001 - (57 pages) | http://www.leu.ch/pdf/pharma_en.pdf |
| TRIPS on Trial - The Impact of WTO’s Patent Regime The Impact of WTO’s Patent Regime On the World’s Farmers, the Poor On the World’s Farmers, the Poor and Developing Countries and Developing Countries -Declaration de Berne September 2001 - (27 pages) | http://www.evb.ch/cm_data/tripsontrial.PDF |
| François Dessemontet - L’épuisement en droit des brevets : un arrêt de principe - CEDIDAC Bulletin d’information n° 32 – Décembre 1999 - (9 pages) | http://www.unil.ch/cedidac/bulletin/bulletin_32.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 |
| H. Peter Steeves - “Start a Line and Get Me a Consent Waiver, STAT!” Autonomy, Community Consultation, and Informed Consent in Emergency Research - (54 pages) | http://www.ars-rhetorica.net/Queen/VolumeSpecialIssue/Articles/Steeves.pdf |
| Lausanne University - Règlement de la Commission Permanente d'Ethique de la Recherche Clinique - (6 pages) | http://www.unil.ch/cercfm/docs/Regl_cercfm_2000.pdf |
| Lausanne University - Recommandations pour la rédaction d'un protocole de recherche soumis à la Commission d'Ethique de la Recherche clinique de la Faculté de Médecine | http://www.unil.ch/cercfm/recommandations.html |
| Lausanne University - Exemple de formulaire de consentement éclairé (consentement écrit) | http://www.unil.ch/cercfm/formulaire.html |
| Lausanne University - Demande d’évaluation de l’essai clinique: | http://www.unil.ch/cercfm/docs/SoumissionLS.dot.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 |
| Académie Suisse des Sciences Médicales Directives pour la recherche expérimentale sur l’être humain - (16 pages) | http://www.samw.ch/content/Richtlinien/f_Forschungsunters.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/ |
| 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 |
| Hippocratic Oath -- Modern Version | http://www.pbs.org/wgbh/nova/doctors/oath_modern.html |
| ASSM - Commission centrale d’éthique Rapport annuel 2000 | http://www.samw.ch/content/Kommissionen/fk_ZEK.htm#Rapport annuel |
| 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 |
| Global Forum for Health Research - home page - "to help correct the 10/90 gap by focusing research efforts on diseases representing the heaviest burden on the world's health " | http://www.globalforumhealth.org/pages/index.asp |
| Global Forum for Health Research - Monitoring Financial Flows for Health Research (publication of 5 chapters) | http://www.globalforumhealth.org/FilesUpld/20.pdf |
| Global Forum for Health Research - The 10/90 Report on Health Research 2000 - (publication of 7 chapters) | http://www.globalforumhealth.org/non_compliant_pages/report00/00intro.pdf |
| ICSU - International Council for Science - home page - "a non-governmental organization, founded in 1931 to bring together natural scientists in international scientific endeavour | http://www.icsu.org/ |
| DIA - Drug Information Journal - freely available except for the 2 most recent years | http://www.diahome.org/docs/multiLang/DIAJournal_index.cfm?PageID=dijindex |
| EFGCP - International Guidelines on Bioethics Informal Listing of Selected International Codes, Declarations, Guidelines, etc. on Medical Ethics/Bioethics/Health Care Ethics/Human Rights Aspects of Health - 3rd Edition - (18 pages) | http://www.efgcp.org/webdocs/international.pdf |
| EFGCP - Optional Guideline for Good Clinical Practice Compliance and Quality Systems Auditing In conformity with the Note for Guidance on GCP CPMP/ICH/135/95 (ICH GCP) | http://www.efgcp.org/webdocs/engage.pdf |
| EFGCP - Guidelines and Recommendations for European Ethics Committees - (18 pages) | http://www.efgcp.org/webdocs/efgcprecommendation.pdf |
| EFGCP - Audit Working Party The handling of Case Report Form (CRF) at an investigational site | http://www.efgcp.org/webdocs/handling_of_CRF.pdf |
| EFGCP - Audit Working Party Protocol Compliance - (6 pages) | http://www.efgcp.org/webdocs/protocol_compliance.pdf |
| EFGCP - Records Management and Archiving Working Party Guidelines for Retention of Clinical Trial Records at Investigator Study Sites - / pages) | http://www.efgcp.org/webdocs/guidelines_for_retention.pdf |
| 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 |
| SIDCDER - home page - "an independent international cooperative project designed to facilitate the development of the ethical review of biomedical research" | http://www.sidcer.net/ |
| The British Medical Journal - home page - access to full-text papers | http://bmj.com/ |
| The Lancet - home page - | http://www.thelancet.com/journal |
| Nature - home page | http://www.nature.com/nature/ |
| Rika Onishi Mortimer - Demand for Prescription Drugs: The Effects of Managed Care Pharmacy Benefits - (57 pages) | http://econwpa.wustl.edu:8089/eps/hew/papers/9802/9802002.pdf |
| Anna Merino-Castelló - The impact of the reference price system on the pharmaceutical market: a theoretical approach- February, 2000 - (32 pages) | http://www.econ.upf.es/deehome/what/wpapers/postscripts/524.pdf |
| Gray, Sidney Skogsvik, Kenth - The Valuation Relevance of Voluntary Disclosures: A Comparative Analysis of the Disclosure Behaviour of Major Pharmaceutical Companies in Sweden and the UK - (25 pag | http://www.econ.upf.es/deehome/what/wpapers/postscripts/524.pdf |
| Gregory S. Crawford and Matthew Shum - Uncertainty and Learning in Pharmaceutical Demand - February 2000 - (42 pages) | ftp://ftp.econ.duke.edu/pub/gsc/match.pdf |
| Gregory Crawford Matthew Shum - State Dependence in Pharmaceutical Prescription Choice: Implications for Physician Authority and Market Structure - 1998 - (19 pages) | ftp://ftp.econ.duke.edu/pub/gsc/habit.pdf |
| Elli Malki - Intellectual property and the valuation of biotechnology companies: GEN-dex versus Dow Jones - (11 pages) | http://econwpa.wustl.edu:8089/eps/fin/papers/9709/9709002.pdf |
| Andreas Pyka and Paolo Saviotti - Innovation Networks in the Biotechnology-Based Sectors - July 2001 - (35 pages) | http://www.wiwi.uni-augsburg.de/vwl/institut/paper/205.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 |
| Thomas Aronsson Mats A. Bergman and Niklas Rudholm - The Impact of Generic Competition on Brand Name Market Shares: Evidence from Micro Data- December 1997 - (22 pages) | http://swopec.hhs.se/hastef/papers/hastef0274.pdf |
| CPTECH - Frequently Asked Questions About HR 626, the `Health Care Research and Development and Taxpayer Protection Act' | http://www.cptech.org/ip/health/econ/rp-faq.html |
| Guillem López-Casasnovas Jaume Puig-Junoy - Review of the Literature on Reference Pricing - April 14th, 2000 - (47 pages) | http://www.econ.upf.es/deehome/what/wpapers/postscripts/362.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 |
| Kaiser Permanente - Institute for Health Policy - Existing Reporting Systems - This document provides an overview of the following existing medical care reporting systems - (20 pages) | http://www.kaiserpermanente.org/medicine/ihp/pdfs/exist_error_rep.pdf |
| Kaiser Permanente - Institute for Health Policy - List of publications | http://www.kaiserpermanente.org/medicine/ihp/publications.html |
| 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 |
| 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 |
| American Academy of Pediatrics - Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Populations (RE9503) | http://www.aap.org/policy/00655.html |
| 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 |
| Centre for Evidence-Based Medicine - home page | http://cebm.jr2.ox.ac.uk/ |
| Infomed
- home page - "Peer-Reviewed Independeht Non-Profit Publications
Without Advertising " " |
http://www.infomed.ch/ |
| 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 |
| Ordonnance du 2 février 2000 sur les Bonnes pratiques de laboratoire (OBPL) | http://www.admin.ch/ch/f/rs/8/813.016.5.fr.pdf |
| Ordonnance du 25 août 1999 sur l'utilisation d'organismes dans l'environnement (Ordonnance sur la dissémination dans l'environnement, ODE) | http://www.admin.ch/ch/f/rs/8/814.911.fr.pdf |
| Ordonnance du 25 août 1999 sur l'utilisation des organismes en milieu confiné (Ordonnance sur l'utilisation confinée, OUC) | http://www.admin.ch/ch/f/rs/8/814.912.fr.pdf |
| GeneBio - home page - "providing quality databases, software tools and services to the Life Science industry particularly in the field of proteomics" | http://www.genebio.com |
| GeneProt - home page - "goal is to become the leader in the discovery, identification and characterization of proteins and their functions for major disabling or life threatening diseases" | http://www.geneprot.com |
| National Council - debate on the initiative "La santé à un prix abordable" | http://www.parlament.ch/ab/frameset/d/n/4605/24029/d_n_4605_24029_24149.htm |
| Schering-Plough - home page | http://www.schering-plough.com/ |
| ICOS - home page - | http://www.icos.com/ |
| Darden - University of Virginia - Genzyme/Geltex pharmaceuticals joint venture- - (do not copy status) - (15 pages) | http://papers.ssrn.com/sol3/delivery.cfm/SSRN_ID200849_code991214200.pdf?abstractid=200849 |
| Productivity Commission 2001 - International Pharmaceutical Price Differences, Research Report, AusInfo, Canberra. - July 2001 - (225 pages) | http://papers.ssrn.com/sol3/delivery.cfm/SSRN_ID277602_code010731670.pdf?abstractid=277602 |
| Brazil, Pharmaceutical Industry and WTO - (87 pages) | http://papers.ssrn.com/sol3/delivery.cfm/SSRN_ID272208_code010605140.pdf?abstractid=272208 |
| Sara
F. Ellison & Christopher M. Snyder - COUNTERVAILING POWER IN
WHOLESALE PHARMACEUTICALS MIT - Department of Economics - Working Paper 01-27 - July 2001 - (40 pages) |
http://papers.ssrn.com/sol3/delivery.cfm/SSRN_ID277290_code010725500.pdf?abstractid=277290 |
| Integrity in Science, Non profit organizations with ties to the industry, a CSPI Project | http://www.cspinet.org/integrity/corp_funding.htm |
| European Aids Treatment Group (EATG), Glaxo SmithKline Delivers Killer Greed- In Time for the Holidays | http://www.eatg.org/news/00/271200.html#greed |
| Kate Schiel, the war on cancer is a fraud, Disinformation, May 13, 2001 | http://www.disinfo.com/pages/dossier/id336/pg1/ |
| Holly Stewart, Vivienne Murray, Premarin The Hidden Costs, Earth Save Canada | http://www.earthsave.bc.ca/materials/articles/art |
| Margaret Duckett, Compulsory Licensing and Parallel Importing: What do they mean? Will they improve access to essential drugs for people living with HIV/AIDS? Background Paper, ICASO, July 1999 | http://www.icaso.org/docs/compulsoryenglish.htm |
| Price Supervisor, Echec du « deal » proposé par l’industrie pharmaceutique, Bern March 4, 1998. | http://www.monsieur-prix.admin.ch/dynamic/cp/PHARMADEAL/F/PHARMADEAL.html |
| Price Supervisor, Le Surveillant des prix s’exprime sur le « deal » prévu par l’industrie pharmaceutique, February 4, 1998, | http://www.monsieur-prix.admin.ch/dynamic/cp/GEPLANTER_PHARMADEAL/F/GEPLANTER_PHARMADEAL.html |
| Price Supervisor, Examen des prix des médicaments, Prise de position du Surveillant des prix, October 2, 1996 | http://www.monsieur-prix.admin.ch/dynamic/cp/UBERPRUFUNG_MEDIPREISE/F/UBERPRUFUNG_MEDIPREISE.html |
| Price Supervisor, Annual Report 2000, DPC 5/2000, at 846 | http://www.monsieur-prix.admin.ch/dynamic/rapport/00_JB/F/Rapport_annuel_2000.pdf |
| Price Supervisor, Annual Report 1998, DPC 1998/5, at 818. | http://www.monsieur-prix.admin.ch/dynamic/rapport/98_JB/F/Rapport_annuel_1998.pdf |
| Price Supervisor, Annual Report 1997, DPC 1997/5 at 726-728. | http://www.monsieur-prix.admin.ch/dynamic/rapport/97_JB/F/Rapport_annuel_1997.pdf |
| Price Supervisor, Annual Report 1996, at 108-111. | http://www.monsieur-prix.admin.ch/dynamic/rapport/96_JB/F/Rapport_annuel_1996.pdf |
| Price Supervisor, Annual Report 1995, at 58-60. | http://www.monsieur-prix.admin.ch/dynamic/rapport/95_JB/F/Rapport_annuel_1995.pdf |
| Price Supervisor, Annual Report 1993 (extract). | http://www.monsieur-prix.admin.ch/dynamic/rapport/93_MEDIKAMENT/F/93-medi_f.pdf |
| Price Supervisor, Annual Report 1992 (extract). | http://www.monsieur-prix.admin.ch/dynamic/rapport/92_MEDIKAMENT/F/92-medi_f.pdf |
| Price Supervisor, Annual Report 1991, (extract) | http://www.monsieur-prix.admin.ch/dynamic/rapport/91_MEDIKAMENT/F/91-medi_f.pdf |
| Price Supervisor, Wettbewerbsmängel bei der Preisgestaltung der Medikamente in der Schweiz, Ein Beitrag zur Revitalisierung - Phase 2, Study of the Price Supervisor with the assistance of the Competition Commission (19 pages) | http://www.monsieur-prix.admin.ch/dynamic/etude/STUDIE_MEDIKAMENTE/F/wettbewerb.pdf |
| Convention intercantonale du 3 juin 1971 sur le contrôle des médicaments | http://www.admin.ch/ch/f/rs/c812_101.html |
| Ordonnance du 23 août 1989 concernant les produits immunobiologique | http://www.admin.ch/ch/f/rs/8/812.111.fr.pdf |
| Loi fédérale du 18 décembre 1970 sur la lutte contre les maladies transmissibles de l'homme (Loi sur les épidémies); RS 818.101 | http://www.admin.ch/ch/f/rs/8/818.101.fr.pdf |
| Arrêté fédéral du 22 mars 1996 sur le contrôle du sang, des produits sanguins et des transplants; RS | http://www.admin.ch/ch/f/rs/8/818.111.fr.pdf |
| ISREC - Swiss Institute for Experimental Cancer Research - home page - "Founded in Lausanne in 1964, subsidized by the Swiss Confederation, Non-profit organization" | http://www.isrec.ch/en_frameset_gen.html |
| ATF 123 I 201 - Pharmacie Victoria SA and Joseph Ghaliounghi against Conseil d'Etat of the canton Geneva - June 24, 1997 | http://www.eurospider.ch/buge3/index/123_I.html |
| ATF 125 I 474 - Decision of the Swiss Federal Tribunal - regarding MediService SA against Conseil d'Etat of the canton Vaud on mail order pharmacies - October 1, 1999 | http://www.eurospider.ch/buge3/index/125_I.html |
| Rapport du Groupe de travail au Département de Justice et Police - Assistance au décès - March 1999 - (55 pages) | http://www.ofj.admin.ch/themen/stgb-sterbehilfe/b-bericht-f.pdf |
| Rapport du Conseil Fédéral donnant suite au postulat Ruffy - Assistance au Décès - Adjonction au Code Pénal Suisse - (15 pages) | http://www.ofj.admin.ch/themen/stgb-sterbehilfe/ber-ruffy-f.pdf |
| BioIsrael - home page -"the hubsite of Israel`s life sciences community and the leading source of news about Israeli biotechnology and medical device companies" | http://www.bioisrael.com |
| Ashish Arora, Alfonso Gambardella,Fabio Pammolli, Massimo Riccaboni, The Nature and the Extent of the Market for Technology in Biopharmaceuticals, EPRIS, - December 2000 - (42 pages) | http://www.unisi.it/epris/abstract/biotec.doc |
| Harvey E. Bale, Consumption and trade in off- patented medicines. ICRIER, Working Paper n° 65 - May, 2001 - (29 pages) | http://www.icrier.res.in/pdf/bale65.PDF |
| John Barton, Differentiated pricing of patented products, ICRIER Working Paper n° 63 - March, 2001 - (27 pages) | http://www.icrier.res.in/pdf/barton63.PDF |
| Novartis - home page | http://www.novartis.com |
| Roche - home page | http://www.roche.com |
| U.S. Federal Drug and Food Administration - FDA - home page | http://www.fda.gov/guidance |
| Ordonnance du 26 juin 1996 sur le contrôle du sang, des produits sanguins et des transplants (Ordonnance sur le contrôle du sang); RS 818.111.3 | http://www.admin.ch/ch/f/rs/8/818.111.3.fr.pdf |
| Ordonnance du 26 juin 1996 sur les essais cliniques de produits immunologiques; RS: 818.124. | http://www.admin.ch/ch/f/rs/8/818.124.1.fr.pdf |
| Ordonnance du 13 janvier 1999 sur la déclaration des maladies transmissibles de l'homme (Ordonnance sur la déclaration); RS 818.141.1 | http://www.admin.ch/ch/f/rs/8/818.141.1.fr.pdf |
| Ordonnance du 24 janvier 1996 sur les dispositifs médicaux (ODim); RS 819.124 | http://www.admin.ch/ch/f/rs/8/819.124.fr.pdf |
| Loi fédérale du 18 mars 1994 sur l'assurance-maladie (LAMal); RS 832.10 | http://www.admin.ch/ch/f/rs/8/832.10.fr.pdf |
| Ordonnance du 27 juin 1995 sur l'assurance-maladie (OAMal); RS 832.102 | http://www.admin.ch/ch/f/rs/8/832.102.fr.pdf |
| Ordonnance du 29 septembre 1995 sur les prestations dans l'assurance obligatoire des soins en cas de maladie (O sur les prestations de l'assurance des soins, OPAS); RS 832.112.31 | http://www.admin.ch/ch/f/rs/8/832.112.31.fr.pdf |
| Loi fédérale du 20 mars 1981 sur l'assurance-accidents (LAA); RS 832.20 | http://www.admin.ch/ch/f/rs/8/832.20.fr.pdf |
| Ordonnance du 19 décembre 1983 sur la prévention des accidents et des maladies professionnelles (O sur la prévention des accidents, OPA); RS 832.30 | http://www.admin.ch/ch/f/rs/8/832.30.fr.pdf |
| Constitution de l'Organisation mondiale de la santé du 22 juillet 1946; RS 0.810.1 | http://www.admin.ch/ch/f/rs/i8/0.810.1.fr.pdf |
| Stability Testing of New Drug Substances and Products (Step 5) | http://www.ifpma.org/pdfifpma/q1arstep4.pdf |
| Guideline on Photostability Testing (Step 5) | http://www.ifpma.org/pdfifpma/q1b.pdf |
| Guideline on Stability Testing for New Dosage Forms Step 5 | http://www.ifpma.org/pdfifpma/q1c.pdf |
| Guideline on Impurities in New Drug Substances (Revised Guideline) (Step 3) | http://www.ifpma.org/word/Q3Arstep2.doc |
| Impurities in New Drug Products (Revised Guideline) (Step 3) | http://www.ifpma.org/word/Q3Brstep2.doc |
| Q6B Guideline on Biotechnological Substances (Step 5) | http://www.ifpma.org/pdfifpma/Q6bstep4.pdf |
| Q7A Guideline on Good Manufacturing Practices for Active Pharmaceutical Ingredients Step 5 | http://www.ifpma.org/pdfifpma/Q7Astep4.PDF |
| Web site of the European Agency for the Evaluation of Medicinal Products (EMEA) | http://www.emea.eu.int/# |
| EMEA Web Site for Human Medicines | http://www.emea.eu.int/index/indexh1.htm |
| EMEA General Information for Sponsors of Orphan Medicinal Products (EMEA/4795/00) | http://www.emea.eu.int/pdfs/human/comp/479500en.p |
| European Commission Enterprise DG | http://pharmacos.eudra.org |
| European Commission, Enterprise Directorate-General, G10 Medicines High Level Group on Innovation and Provision of Medicines, Single market, implementation and legislation for consumer goods, Consultation Paper, p 20 | http://pharmacos.eudra.org/F3/g10/docs/g10an1.pdf |
| Information on the high level group on Innovation and the Provision of Medicines | http://pharmacos.eudra.org/F3/g10/p2.htm |
| Report
from the Commission on the experience acquired as a result of the
operation of the procedures for granting marketing authorisations for medicinal products laid down in Regulation (EEC) N° 2309/93, 2001, (p 33) |
http://pharmacos.eudra.org/F2/review/doc/reviewra |
| European Commission, Enterprise Directorate-General, Pharmaceutical Legislation Review 2001, Single market : management & legislation for consumer goods Pharmaceuticals : regulatory framework and market authorisations, (p 77) | http://pharmacos.eudra.org/F2/review/doc/2codehum |
| Reform of EU Pharmaceutical Legislation, Brussels, 18 July 2001, MEMO/01/267 | http://pharmacos.eudra.org/F2/review/doc/brief_m0 |
| List of directives and regulations of the European Union regarding proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/reg/en_regist |
| Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1965/en_3 |
| Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 |
| Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1975/en_3 |
| Council Directive 78/25/EEC of 12 December 1977 on the approximation of the laws of the Member States relating to the colouring matters which may be added to medicinal products | http://europa.eu.int/eur-lex/en/lif/dat/1978/en_3 |
| Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens | http://europa.eu.int/eur-lex/en/lif/dat/1989/en_3 |
| Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials | http://europa.eu.int/eur-lex/en/lif/dat/2001/en_3 |
| Commission Regulation (EC) No 2141/96 of 7 November 1996 concerning the examination of an application for the transfer of a marketing authorization for a medicinal product falling within the scope of Council Regulation (EC) No 2309/93 | http://europa.eu.int/eur-lex/en/lif/dat/1996/en_3 |
| Home Page of the Center for Drug Evaluation and Research (FDA) - home page | http://www.fda.gov/cder/ |
| List of Guidance Documents of CDER | http://www.fda.gov/cder/guidance/index.htm |
| Center for Drug Evaluation and Research, 2000 Report to the Nation Improving Public Health Through Human Drugs | http://www.fda.gov/cder/reports/RTN2000/RTN2000.P |
| Center for Drug Evaluation and Research, CDER 1999 Report to the Nation Improving Public Health Through Human Drugs | http://www.fda.gov/cder/reports/rtn99.pdf |
| CDER, 1997 Report to the Nation: Improving Public Health Through Human Drugs | http://www.fda.gov/cder/reports/rptntn97.pdf |
| Swiss Federal Office for Public Health, Annual Report 2000 on biologic products | http://www.bag.admin.ch/heilmitt/biologik/jahrb00 |
| Swiss Federal Law on Therapeutic Products (English Translation); RS | http://www.bag.admin.ch/heilmitt/gesetz/HMG_Engl. |
| Swiss Department of Home Affairs, Rapport de consultation concernant les ordonnances sur les produits thérapeutiques Berne, 17 octobre 2001 | http://www.bag.admin.ch/heilmitt/aktuell/d/verord |
| Canton of Geneva, Dons d'organes - loi genevoise: du consentement explicite au consentement présumé | http://www.geneve.ch/social/donsorg/welcome.html |
| E-Letter on Drugs for Severe Psychiatric Illnesses, Public Citizen | http://www.citizen.org/eletter/# |
| Medscape - home page | http://www.medscape.com/ |
| Washington Post, The Body Hunters, | http://www.washingtonpost.com/wp-dyn/world/issues/bodyhunters/ |
| Biotechnology Information Switzerland, Information on biotechnology with a focus on Switzerland | http://www.bioweb.ch/en/ |
| Actelion - home page - Swiss biotechnology company | http://www.actelion.com/ |
| Advanced Drug Delivery Technologies Ltd. - home page - a Swiss company | http://www.addtechnologies.com/ |
| The Pharmaceutical Research and Manufacturers of America (PhRMA) - home page | http://www.phrma.org/ |
| Swiss Center for Technology Assessment - Anne Eckhard - Somatic gene therapy: Striking to the roots of disease | http://www.ta-swiss.ch/www-support/reportlists/reports_temp/ta_32a_99_kurz_e.pdf |
| Swiss Centre for Technology Assessment - RESEARCH ON HUMAN SUBJECTS: UK DEBATE - September 2001 - (4 pages) | http://www.ta-swiss.ch/www-support/news/Materials_news_temp/human_research.pdf |
| Loi fédérale sur les médicaments et les dispositifs médicaux (Loi sur les produits thérapeutiques - LPT - December 15, 2000 | http://www.admin.ch/ch/f/ff/2000/5689.pdf |
| Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Devices Directive, Article 10 | http://www.bag.admin.ch/md/pdf/ivdform-fe.pdf |
| Form for the registration of information relating to certification of In Vitro Diagnostic Medical Devices (Annexes III to VII) - In Vitro Diagnostic Medical Devices Directive | http://www.bag.admin.ch/md/pdf/ivdzert-fe.pdf |
| Normes techniques pour les dispositifs médicaux - Ordonnance sur les dispositifs médicaux (ODim) | http://www.bag.admin.ch/md/pdf/normenf.pdf |
| Liste des numéros d’identification des organes responsables de l’évaluation de la conformité des dispositifs médicaux reconnus en Suisse (articles 8 et 11 ODim) July 3, 2001 | http://www.bag.admin.ch/md/pdf/kbs-f.pdf |
| Demande pour l'évaluation d'un projet de recherche biomédicale, élaboré sous la direction de l’Académie suisse des sciences médicales (ASSM/SAMW) en accord avec les commissions d’éthique, les cantons, l’OICM et l’OFSP. | http://www.samw.ch/content/Formulare/f_FormEKAntrag.doc |
| Notification according to art. 6 MDO - one notification for each device or group of devices. | http://www.bag.admin.ch/md/pdf/me-formdfie.pdf |
| Dispositifs médicaux: annonce des incidents par les utilisateurs | http://www.bag.admin.ch/md/pdf/vi_factf.pdf |
| Edward M. Basile, Ellen Armentrout & Kelly N. Reeves, Medical Device Labeling and Advertising: An Overview, 54 Food and Drug Law Journal 519-534 (1999) - (16 pages) | http://www.fdli.org/pubs/Journal%20Online/54_4/art2.pdf |
| J. Howard Beales III, Modification and Consumer Information: Modern Biotechnology and the Regulation of Information, 55 Food and Drug Law Journal 105-118 (2000) - (14 pages) | http://www.fdli.org/pubs/Journal%20Online/55_1/art6.pdf |
| Eric M. Blumberg, Abbott Laboratories Consent Decree and Individual Responsibility Under the Federal Food, Drug, and Cosmetic Act, 55 Food and Drug Law Journal 145-150 (2000) - (6 pages) | http://www.fdli.org/pubs/Journal%20Online/55_1/art9.pdf |
| Robert A. Book, Public Research Funding and Private Innovation: The Case of the Pharmaceutical Industry, December 2000 - (72 pages) | http://home.uchicago.edu/~rabook/Book_PharmInnov.pdf |
| Maureen McKelvey* and Luigi Orsenigo - Pharmaceuticals as a Sectoral Innovation System - November 2001 - (74 pages) | http://www.cespri.uni-bocconi.it/essy/mckelors.PDF |
| Alan Sager, Deborah Socolar, Cutting Prescription Drug Spending by Paying Federal Supply Schedule Prices - Boston University - August 2000 - (49 pages) | http://dcc2.bumc.bu.edu/hs/sager/Cutting%20Rx%20prices%20in%208%20northeast%20states%202%20Aug%2000.pdf |
| Nicola Lacetera and Luigi Orsenigo - Political regimes, technological regimes and innovation in the evolution of the pharmaceutical industry in the USA and in Europe - CEPRIS - March 2001 - (rough draft) - (59 pages) | http://www.unisi.it/ricerca/prog/epris/abstract/pdf/Lacetera-Orsenigo-Baltimore2.PDF |
| ERPIS - home page - "The main objective of EPRIS is to develop a comprehensive analysis of the structure and evolution of the European Pharmaceutical Regulation and Innovation Systems" | http://www.unisi.it/ricerca/prog/epris/index.htm |
| OHE - The Office of Health Economics - home page | http://www.ohe.org/ |
| CenterWatch - home page - "We provide information services used by patients, pharmaceutical, biotechnology and medical device companies, CROs and research centers involved in clinical research around the world" | http://www.centerwatch.com |
| American Medical News - home page | http://www.ama-assn.org/public/journals/amnews/amnews.htm |
| Société suisse des pharmaciens - home page | http://www.pharmagate.ch/index_f.html |
| Message du Conseil fédéral concernant l'initiative populaire pour des médicaments à moindre prix - May 12, 1999 - (25 pages) | http://www.admin.ch/ch/f/ff/1999/6813.pdf |
| Accord entre la Communauté européenne et la Confédération suisse relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité - FF 1999 5847 - (80 pages) | http://www.europa.admin.ch/ba/off/abkommen/f/abf_tbt.pdf |
| Rapport du Conseil fédéral sur l’inventaire et l’évaluation des procédures de droit fédéral de l’économie (Réponse au Postulat David 96.3607 «Charges administratives») - February 17, 1999 - (181 pages, at 84, 101, 113, 172) | http://www.admin.ch/ch/f/ff/1999/7603.pdf |
| Swiss Parliament - National Council - debate on euthanasia - December 11, 2001 | http://www.parlament.ch/ab/frameset/f/n/4611/44739/f_n_4611_44739_44740.htm |
| Swiss Parliament - National Council - debate on euthanasia - December 11, 2001 | http://www.parlament.ch/ab/frameset/f/n/4611/44739/f_n_4611_44739_44842.htm |
| Program on the Pharmaceutical Industry - MIT Sloan School of Management - Cambridge, Massachusetts | http://web.mit.edu/popi/ |
| Swiss Federal Council, Message concernant l’initiative populaire "La santé à un prix abordable (initiative-santé)“ du 31 mai 2000 . FF 2000 3931 - (54 pages) | http://www.admin.ch/ch/f/ff/2000/3931.pdf |
| Federal
Council - Message relatif à l’initiative populaire «pour un
approvisionnement en médicaments sûr et axé sur la promotion de la
santé (Initiative sur les médicaments)» du 1er mars 2000 - FF 200 1964- (16 pages) |
http://www.admin.ch/ch/f/ff/2000/1964.pdf |
| Pfizer - home page | http://www.pfizer.com/main.html |
| Merck - home page | http://www.merck.com/ |
| Merck - The Merck Manual of Medical Information--Home Edition | http://www.merck.com/pubs/mmanual_home/contents.htm |
| Swiss Competition Commission - Accords sur les prix/répartition des ventes sur le marché des vitamines - DPC 2000/2 at 186-196. | http://www.wettbewerbskommission.ch/site/f/dpc/dpc.Par.0004.Pic1.pdf |
| Swiss Medical Association - home page | http://www.fmh.ch/ |
| Medabiotech - home page | http://www.medabiotech.com/ |
| Decision of the Swiss Federal Tribunal of November 1, 2001 - 2P.67/2001 | http://wwwsrv.bger.ch/cgi-bin/AZA/MapProcessorCGI_AZA?mapfile=pull/ConvertDocFrameCGI.map&ri=fr&lang=fr&ds=AZA_pull&d=01.11.2001_2P.67%2f2001&pa=2%7emelatonine%4010%7emelatonine%404%7e& |
| Decision of the Swiss Federal Tribunal - ATF 118 V 56 - January 30, 1992 - regarding admission of a pharmaceuticals to the reimbursement list | http://www.eurospider.ch/buge3/index/118_V.html |
| Decision of the Swiss Federal Tribunal - ATF 120 II 248 - July 29, 1994 - regarding physicians' liability | http://www.eurospider.ch/buge3/index/120_II.html |
| Decision of the Swiss Federal Tribunal - ATF120 V 76 -May 12, 1976 - regarding admission of a pharmaceuticals to the reimbursement list | http://www.eurospider.ch/buge3/index/120_V.html |
| Decision of the Swiss Federal Tribunal - ATF 118 V 274 - December 4, 1992 - regarding reimbursement of a pharmaceuticals by a sickness insurance company | http://www.eurospider.ch/buge3/index/118_V.html |
| Decision of the Swiss Federal Tribunal - ATF107 V 167 - June 4, 1981 - regarding reimbursement of a pharmaceutical by a sickness insurance company | http://www.eurospider.ch/buge3/index/107_V.html |
| Decision of the Swiss Federal Tribunal - ATF124 III 375 - July 10, 1998 - regarding pharmaceuticals' certificate of complementary protection | http://www.eurospider.ch/buge3/index/124_III.html |
| Decision of the Swiss Federal Tribunal - ATF 81 I 351 -October 26, 1955 - regarding fees for obtaining marketing authorizations | http://www.eurospider.ch/buge3/index/81_I.html |
| Decision of the Swiss Federal Tribunal - ATF 109 V 197 - April 14, 1983 - regarding pharmaceuticals' admission to the reimbursement list | http://www.eurospider.ch/buge3/index/109_V.html |
| Decision of the Swiss Federal Tribunal - ATF 120 V 481 - October 13, 1994 - regarding physicians' prescription of a pharmaceutical product | http://www.eurospider.ch/buge3/index/120_V.html |
| Decision of the Swiss Federal Tribunal - ATF 105 V 186 - September 10, 1979 - regarding pharmaceuticals' admission to the reimbursement list | http://www.eurospider.ch/buge3/index/105_V.html |
| WIPO, Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing Countries | http://www.wipo.org/about-ip/en/studies/pdf/ssa_maskus_pi.pdf |
| Interpharma, Study of BAK Importance de l'industrie chimique et pharmaceutique pour l'économie suisse Garante et moteur de la productivité et de la prospérité en Suisse (30 pages) | http://www.interpharma.ch/themen/ghpolit/archiv/pdf/BAK-f.pdf |
| Interpharma, Des recherches et des médicaments pour le bien de votre santé | http://www.interpharma.ch/themen/medi/archiv/pdf/vom-f.pdf |
| Interpharma, Etude de tendance GfS "Moniteur de la santé 2001 " Qualité, prestations et liberté de choix ne doivent pas être restreintes - (8 pages) | http://www.interpharma.ch/info/wissens/pharma_ch/zeitung/f/pdf/01_04_f.pdf |
| Interpharma - GfS Institut de recherche - Orientation sur la qualité et les coûts - September 24, 2001, (also http://www.interpharma.ch/themen/ghpolit/gmonitor_01/gmonitor01-pict-f.pdf) | http://www.interpharma.ch/themen/ghpolit/gmonitor_01/gmonitor01-f.pdf |
| Interpharma, La santé publique en Suisse Prestations, coûts, prix - 2000 - (80 pages) | http://www.interpharma.ch/info/wissens/gesundheit/pdf/BlauB_f00.pdf |
| Price of pharmaceuticals from the Swiss reimbursement list | http://www.sl-preise.ch/ |
| Tufts Center for the Study of Drug Development | http://www.tufts.edu/med/csdd/index.html |
| Tufts Center, Outlook 2001 - (12 pages) | http://www.tufts.edu/med/csdd/images/otlk2001.pdf |
| Tufts Center - A Methodology for Counting Costs for Pharmaceutical R&D - November 30, 2001 - (4 pages) | http://www.tufts.edu/med/csdd/images/StudyMethodology.pdf |
| Biotechnology Industry Organization - home page | http://www.bio.org/ |
| BIO - Genomics - PRIMER: GENOME AND GENETIC RESEARCH, PATENT PROTECTION AND 21 st CENTURY MEDICINE - July 2001 | http://www.bio.org/genomics/primer.html |
| BIO - Statement on patent-term amendments to protect diligent patent applicants and 18-month publication of patent applications before the Courts and Intellectual Property Subcommittee | http://www.bio.org/laws/tstm2261.html |
| BIO - Guide on biotechnology - (120 pages) | http://www.bio.org/aboutbio/guide2001/letter.pdf |
| DIA - Drug Information Association - home page | http://www.diahome.org |
| PharmWeb - "the premier online community of pharmaceutical and healthcare-related professionals with approximately 25,000 self-registered users" | http://www.pharmweb.net/ |
| Decision of the Geneva Administrative Tribunal - January 23, 2001 - regarding sale of unapproved medicines | http://justice.geneve.ch/jurisprudence/pjdoc.tdb?L=14624 |
| Decision of the Geneva Administrative Tribunal - August 23, 2000 - regarding sale of an unapproved medicine | http://justice.geneve.ch/jurisprudence/pjdoc.tdb?L=14289 |
| Decision of the Geneva Administrative Tribunal - March 23, 2000 - regarding sale of unapproved product | http://justice.geneve.ch/jurisprudence/pjdoc.tdb?L=13140 |
| Decision of the Geneva Administrative Tribunal - July 28, 1998 - regarding sale of product presented as homeopathic but containing active substances | http://justice.geneve.ch/jurisprudence/pjdoc.tdb?L=12149 |
| Geneva
Law - Loi sur l’exercice des professions de la santé, les établissements
médicaux et diverses entreprises du domaine médical - K 3 05 |
http://www.geneve.ch/legislation/rsg/f/rsg_k3_05.html |
| Geneva Regulation on Health - Règlement d’exécution de la loi sur l’exercice des professions de la santé, les établissements médicaux et diverses entreprises du domaine médical - K 3 05.01 - July 25, 2001, in force since September 1, 2001 | http://www.geneve.ch/legislation/rsg/f/rsg_k3_05p01.html |
| The European Group on Ethics in Science and new Technologies - - Adoption of an Opinion on Ethical Aspects of Stem Cell Research and Use- January 2001 - (230 pages) | http://www.europa.eu.int/comm/european_group_ethics/docs/dp15.pdf |
| The European Group on Ethics in Science and New Technologies to the European Commission - General Report on its activities 1998-2000 - (163 pages) | http://www.europa.eu.int/comm/european_group_ethics/docs/rap_en.pdf |
| European Commission Directorate - General XII Science, Research and Development- Biotechnology R&D in Europe - 1996 - (37 pages) | http://europa.eu.int/comm/research/biotech/national.pdf |
| European Commission, Directorate - General XII Science, Research Development - Coordination of Structural Biology in Europe, National EC and Industry Joint Efforts - (156 pages) | http://europa.eu.int/comm/research/biotech/structur.pdf |
| COMMUNICATION
FROM THE COMMISSION TOWARDS A STRATEGIC VISION OF LIFE SCIENCES AND
BIOTECHNOLOGY: CONSULTATION DOCUMENT - Brussels, September 4, 2001 - (32 pages) |
http://europa.eu.int/comm/biotechnology/pdf/doc_en.pdf |
| European Parliament: Temporary Committee on Human Genetics and Other New Technologies in Modern Medicine - Report on the ethical, legal, economic and social implications of human genetics - November 8, 2001 - | http://www.europarl.eu.int/comparl/tempcom/genetics/rapfin/rapfin_en.doc |
| Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine) (Oviedo Convention) - April 4, 1997 | http://www.legal.coe.int/bioethics/gb/pdf/convention.pdf |
| Explanatory Report to the Convention for thze Protection of human rights and dignity of the human being with regard to the application of biology and medicine convention on human rights and biomedicines - 36 pages) | http://www.legal.coe.int/bioethics/gb/pdf/rapport.pdf |
| Council of Europe - Recommendation 934 (1982) on genetic engineering | http://stars.coe.fr/ta/ta82/erec934.htm |
| Council of Europe - Recommendation 1046 (1986) on the use of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial purposes | http://stars.coe.fr/ta/ta86/erec1046.htm |
| Council of Europe - RECOMMENDATION 1100 (1989)1 on the use of human embryos and foetuses in scientific research | http://stars.coe.fr/ta/ta89/erec1100.htm |
| Council of Europe - Recommendation 1240 (1994) on the protection and patentability of material of human origin | http://stars.coe.fr/ta/ta94/erec1240.htm |
| Council of Europe - Recommendation 1425 (1999) on Biotechnology and intellectual property | http://stars.coe.fr/ta/ta99/erec1425.htm |
| Council of Europe - Recommendation 1512 (2001) on the Protection of the human genome by the Council of Europe | http://stars.coe.fr/ta/TA01/EREC1512.htm |
| Council of Europe - Additional Protocol to the Oviedo Convention on the Prohibition of Cloning Human Beings and Explanatory report to the Protocol | http://www.legal.coe.int/bioethics/gb/pdf/proto.pdf |
| IBC, International Bioethics Committee - Working Group on genetic data - Draft Report on Collection, Treatment, Storage and Use of Genetic Data - September 3, 2001 | http://www.unesco.org/ibc/en/reports/DraftRep_UseOf_GenData_E.pdf |
| International Bioethics Committee (IBC)- The Use of Embryonic Stem Cells In Therapeutic Research - April 6, 2001 - (24 pages) | http://www.unesco.org/ibc/en/reports/embryonic_ibc_report.pdf |
| Swiss Technology Assessment Center- Schweizerischen Wissenschafts- und Technologierat, Zentrum für Technologiefolgen-Abschätzung - Technologiefolgen-Abschätzung Zelluläre Xenotransplantation - March 2001 - (355 pages) | http://www.ta-swiss.ch/www-remain/projects_archive/life_sciences/TA_39_2001_Bericht_Huesing.pdf |
| Center
for Technology Assessment - Federal Office of Public Health - Swiss
National Science Foundation - Transplantation Medicine 24 - 27. november 2000 at Bern - (52 pages) |
http://www.ta-swiss.ch/www-remain/reports_archive/publications/2000/TA_P2_2000e.pdf |
| Medical Devices Ordinance (MDO) Information on Article 13 Reporting of serious incidents | http://www.bag.admin.ch/md/pdf/VI-Indus-InfoE.pdf |
| Check list of documents required - Annonce d'investigations cliniques avec des dispositifs médicaux | http://www.bag.admin.ch/md/pdf/kl-checklistdfie.pdf |
| European Committee for Standardization - CEN - home page | http://www.cenorm.be/ |
| The International Organization for Standardization (ISO) - home page - "a non-governmental organization" & "a worldwide federation of national standards bodies from some 140 countries, one from each country". | http://www.iso.ch/iso/en/ISOOnline.openerpage |
| Directives techniques sur le don de sang - | http://www.bag.admin.ch/heilmitt/biologik/gesetze/f/nat_rlin.pdf |
| Le Conseil fédéral veut réglementer la recherche sur les cellules souches embryonnaires dans une loi fédérale spécifique - Press release - November 21, 2001 | http://www.bag.admin.ch/dienste/medien/2001/f/01112137.htm |
| Commission d'experts du secret professionnel en matière de recherche médicale - Rapport d'activité pour les années 1998, 1999, 2000 - (25 pages) | http://www.bag.admin.ch/themen/weitere/expkmedf/t_ber_f.pdf |
| Le Conseil fédéral met en vigueur les ordonnances relatives à la loi sur les produits thérapeutiques - Press release of October 17, 2001 | http://www.bag.admin.ch/dienste/medien/2001/f/01101731.htm |
| Draft - New Swiss Federal law on patents - (Loi sur les brevets, LBI) | http://www.ejpd.admin.ch/Doks/vl/patg_ges-f.pdf |
| Explicative report regarding the draft new Federal Law on patents - (93 pages) | http://www.ejpd.admin.ch/Doks/vl/patg_ber-f.pdf |
| Annual report of the Federal Institute for Intellectual Property - (29 pages) | http://www.ige.ch/F/institut/pdf/i102jb01f.pdf |
| Federal Department of Justice and Police - Biotechnologie et droit des brevets: Rapport sur la brevetabilité des inventions concernant les organismes - August 1993 - (52 pages) | http://www.ige.ch/F/jurinfo/pdf/j140_biof.pdf |
| list of medicines subject to prescription, 2000 edition | http://www.coe.fr/soc-sp/sante/Alpha%20List%202000%20E.zip |
| Council of Europe - Committee of Ministers - Resolution AP(2000) on the classification of medicines which are obtainable only on medical prescription - March 15, 2000 | http://cm.coe.int/ta/res/resAP/2000/2000xp1.htm |
| Council of Europe - Committee of Ministers . Resolution AP (99) 2- on warning phrases for certain categories of medicines | http://www.coe.fr/cm/ta/res/resAP/1999/99xp2.htm |
| Council of Europe - Committee of Ministers - Resolution AP (96) - on the declaration of excipients present in pharmaceutical products - October 2, 1996 | http://cm.coe.int/ta/res/1996/96xp1.html |
| Public Health Committee - Committe of experts on pharmaceutical questions - Note from the Austrian Delegation on the requirements applying to prescriptions - Medicines for human use except narcotics | http://www.coe.fr/soc-sp/sante/97spt19reve.zip |
| Public Health Committe - Committee of experts on pharmaceutical questions - Final Report on Generic Medicines - April 2000 | http://www.coe.fr/soc-sp/sante/CD-P-SPT%20(2000)%2027%20E%20-generic%20medicines.zip |
| Public Health Committee - Committee of experts on pharmaceutical questions - Final Report on the importation of unregistered medicines - Multicountry comparisons - April 2000 | http://www.coe.fr/soc-sp/sante/SPT28E%20-%20médicaments%20non%20enregistrés%20-%20Autriche.zip |
| FDA, Devices classification - previous correspondance | http://www.fda.gov/cdrh/devadvice/21.html#contents |
| FDA - Product Code Classification Database | http://www.fda.gov/cdrh/prodcode.html |
| FDA - Good Manufacturing Practices (GMP) / Quality System (QS) Regulation | http://www.fda.gov/cdrh/devadvice/32.html#contents |
| FDA - CDRH Annual Report Fiscal Year 2000 | http://www.fda.gov/cdrh/annual/fy2000/annualreport-2000.pdf |
| FDA - Breast Implants - An Information Update - 2000 - (82 pages) | http://www.fda.gov/cdrh/breastimplants/indexbip.PDF |
| FDA - Bovine Spongiform Encephalopathy (BSE) | http://www.fda.gov/cber/bse/bse.htm |
| FDA - CBER Guidances / Guidelines / Points to Consider | http://www.fda.gov/cber/guidelines.htm |
| FDA - CBER - Blood Publications | http://www.fda.gov/cber/blood/bldpubs.htm |
| FDA - CBER - Tissue Related Documents | http://www.fda.gov/cber/tissue/docs.htm |
| Merrill Matthews - Prices, Profits and Prescriptions: The Pharmatech Industry in the New Economy - December 2001 | http://www.washingtonpolicy.org/HealthCare/PBMatthewsDrugPrices.html |
| John Kamp, Daniele Troy, Elizabeth Alexander - FDA Marketing v. First Amendment: Washington Legal Foundation Legal Challenges to Off-Label Policies May Force Unprecedented Changes at FDA - 54 Food and Drug Law Journal - (12 pages) | http://www.fdli.org/pubs/Journal%20Online/54_4/art4.pdf |
| Richard F. Kingham and Grant H. Castle - Data and Marketing Exclusivity for Pharmaceuticals in the European Community - 55 Food and Drug Law Journal 209 - (16 pages) | http://www.fdli.org/pubs/Journal%20Online/55_2/art3.pdf |
| Swiss Department of Home Affairs - Rapport de consultation concernant les ordonnances sur les produits thérapeutiques - October 17, 2001 - (18 pages) | http://www.bag.admin.ch/heilmitt/aktuell/d/verordnungen/Rapport%20de%20consultation%20OPT%2017.10.01%20zum%20Druck-f.pdf |
| Conference on neglected disease of March 2002 - home page | www.neglecteddiseases.org |
| Patrice Trouiller, Els Torreele, Piero Olliaro, Nick White, Susan Foster, Dyann Wirth and Bernard Pecoul - Drugs for neglected diseases: a failure of the market and a public health failure? - Tropical Medicine and International Health - November 2001 | http://www.neglecteddiseases.org/tmih.pdf |
| Doctors without border, Fatal Imbalance, The Crisis in Research and Development for Drugs for Neglected Diseases - September 2001 - (21 pages) | http://www.doctorswithoutborders.org/publications/reports/2001/fatal_imbalance_short.pdf |
| Special Programme for Research and Training in Tropical Diseases (TDR) - home page - "TDR focuses on neglected infectious diseases that disproportionally affect poor and marginalized populations" | http://www.who.int/tdr/ |
| United Nations Development Programme - home page - "UNDP provides funds; helps developing countries attract and use aid effectively" | http://www.undp.org/ |
| Doctors without Border - home page | http://www.doctorswithoutborders.org/ |
| MSF Campaign for Access to Essential Medicines - home page | http://www.accessmed-msf.org/index.asp |
| Venture.ch - home page - "une initiative commune de McKinsey & Company, Switzerland et de l'EPF de Zurich. Elle a pour but de promouvoir la création d'entreprise" | http://www.venture.ch/fr_default.asp |
| Bioweb - home page - | http://www.bioweb.ch/en/ |
| BICS - home page - Biotechnology Information and Communication Switzerland of the Priority Programme Biotechnology of the Swiss National Science Foundation | http://bics.ch/en/index.php3 |
| Bioweb - Forum - 1/01 - Directives éthiques pour la révolution biomédicale | http://bioweb.ch/fr/forum/2001/1/ |
| FDA - Participation of Racial/Ethnic Groups in Clinical Trials and Race-Related Labeling: A Review of New Molecular Entities Approved 1995-1999 - | http://www.fda.gov/cder/reports/race_ethnicity/race_ethnicity_report.htm |
| PERF - Pan European Regulatory Forum - home page - "The ultimate aim of this programme is the transposition of all technical regulations and European technical acts into the national legislation of central and eastern European countries (CEECs)" | http://perf.eudra.org/ |
| NERA - Policy Relating to Generic Medicines in the OECD - Study carried out on behalf of the European Commission - (237 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/nerareport.pdf |
| Impact of electronic commerce on the European Pharmaceutical Sector - An overview by Ashurst Morris Crisp and Executive Perspective S.A.- November 1998 - (84 pages) | http://pharmacos.eudra.org/F2/smarket/pdf/EU-Pharma-Final.pdf |
| European Commission - Pharmaceuticals in the European Union - Information brochure - (42 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/pharmaeu.pdf |
| European DG Enterprise - Inventory of Community and national incentive measures to aid the research, marketing, development and availability of orphan medicinal products - (17 pages) | http://pharmacos.eudra.org/F2/orphanmp/doc/inventory/Inventory-en.pdf |
| Draft Guideline on the format and content of applications for designation as orphan medicinal products and on the transfer of designations from one sponsor to another, revision December 2000 | http://pharmacos.eudra.org/F2/pharmacos/docs/Doc2000/dec/format-content-rev3.pdf |
| COMMISSION REGULATION (EC) No 847/2000 of 27 April 2000 laying down the provisions for implementation of the criteria for designation of a medicinal product as an orphan medicinal product and definitions of the concepts | http://pharmacos.eudra.org/F2/orphanmp/doc/rev1/en1.pdf |
| REPORT on the communication from the Commission on the Single Market in Pharmaceuticals (COM(98)0588 - C4-0127/99) - April 21, 1999 - (18 pages) | http://pharmacos.eudra.org/F2/smarket/pdf/cemaipen.pdf |
| Third Round Table "Completing the Single Pharmaceutical Market" - December 7, 1998, (77 pages) | http://pharmacos.eudra.org/F2/smarket/pdf/Roundt3.pdf |
| Directive 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use | http://www.europa.eu.int/eur-lex/en/lif/dat/2001/en_301L0020.html |
| The rules governing medicinal products in the European Union - Pharmaceutical legislation- Medicinal products for human use- Volume I -1998 - (294 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol1/vol1en.pdf |
| Notice to Applicants Volume 2A - Procedures for marketing autorisation | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2aen.pdf |
| Notice to Applicants - Volume 2B - Medicinal products for human use - Presentation and content of the dossier - 1998 - (206 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol2/vol2ben.pdf |
| Guidelines - Volume 3A - Medicinal products for human use - Quality and biotechnology - 1998 - (417 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/vol3aen.pdf |
| Guidelines - Volume 3B - Medicinal products for human use - Safety, environment and information - 1998 - (240 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3ben.pdf |
| Guidelines - Volume 3C - Medicinal products for human use - Efficacy - 1998 - (402 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol3/Vol3cen.pdf |
| Volume 4 - Good manufacturing practices - Medicinal products for human and veterinary use - (153 pages) | http://pharmacos.eudra.org/F2/eudralex/download/volpdf/vol4/vol4en.pdf |
| European Commission - Revision of Annex 14 to the EU Guide to Good Manufacturing Practice - Manufacture of medicinal products1 derived from human blood or human plasma - (7 pages) | http://pharmacos.eudra.org/F2/eudralex/vol-4/pdfs-en/gmpan14_en.pdf |
| Technology Review - Biotech - home page - "An MIT enterprise" | http://www.technologyreview.com/biotech.asp |
| New Scientist.com | http://www.newscientist.com/ |
| U.S. Department of Justice and the Federal Trade Commission - Antitrust Guidelines for the Licensing of Intellectual Property - April 1996 | http://www.usdoj.gov/atr/public/guidelines/ipguide.htm |
| Department of Justice and Federal Trade Commission - Statements of antitrust enforcement policy in health care | http://www.ftc.gov/reports/hlth3s.htm |
| FTC Antitrust Actions in health care services and products - June 2001 | http://www.ftc.gov/bc/hcindex/hcupdate.pdf |
| FTC
- Analysis to Aid Public Comment - proposed consent order with Hoechst
Marion Roussel, Inc. (“HMR”), Carderm Capital, L.P. (“Carderm”), and Andrx Corporation (“Andrx”) - (7 pages9 |
http://www.ftc.gov/os/2001/04/hoechstanalysis.pdf |
| FTC - Complaint - against Schering-Plough Corporation, Upsher-Smith Laboratories, American Home Products Corporation, | http://www.ftc.gov/os/2001/04/scheringpart3cmp.pdf |
| Cipla - home page | http://www.cipla.com/ |
| Healthy People 2010: Volume II (second edition) (664 pages) - Chapter 17 on Medical Product Safety - (20 chapters) | http://www.health.gov/healthypeople/Document/pdf/Volume2/17Medical.pdf |
| Virology Education - home page - "Our field of interest is the area of Virology, specifically HIV-AIDS care" | http://www.virology-education.com |
| Unaids - Progress report - ACCELERATING ACCESS TO HIV/AIDS CARE, TREATMENT AND SUPPORT - Updated November 2001 - (23 pages) | http://www.unaids.org/acc_access/AAprogress1101.doc |
| An Assessment of US Pharmaceutical Donations - Edited by Michael R. Reich - Harvard School of Public Health | http://www.hsph.harvard.edu/faculty/reich/donations/ |
| Arti K. Rai & Rebecca S. Eisenberg - The Public and the Private in Biopharmaceutical Research - (20 pages) | http://www.law.duke.edu/pd/papers/raieisen.pdf |
| FTC - Statement of Susan A. Creighton, Deputy Director, Bureau of Competition Regarding FTC Settlement with Hearst Corporation - November 20, 2001 - news release | http://www.ftc.gov/opa/2001/11/hearst.htm |
| FTC - Five Manufacturers of Over-the-Counter Analgesic Products Agree to Settle Charges of Mislabeling Certain Products as "Made in USA" - November 6, 2001 - press release | http://www.ftc.gov/opa/2001/11/musa.htm |
| FTC -FTC Staff Comments on FDA’s Plans to Collect Information on Direct-To-Consumer Prescription Drug Advertising - September 24, 2001 - | http://www.ftc.gov/be/v010008.htm |
| Pontifical Academy for life - Declaration on the production and the scientific and therapeutic use of human embryonic stem cells | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20000824_cellule-staminali_en.html |
| Pontifical Academy for life - statement on the so-called "morning-after pill" | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_20001031_pillola-giorno-dopo_en.html |
| Pontifical Academy for life - Reflections on Cloning | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_30091997_clon_en.html |
| Pontifical Academy for life - identity and Statute of Human Embryos | http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/rc_pa_acdlife_doc_06041998_embrione_en.html |
| Guilio Bottazzi, Giovanni Dosi, Marco Lippi, Fabio Pammolli, Massimo Riccaboni Innovation and Corporate Growth in the Evolution of the Drug Industry, EPRIS, July 2000 | http://www.unisi.it/epris/abstract/pdf/geroski.pdf |
| Leah Brannon, Regulating Drug Promotion on the Internet, 54 Food and Drug Law Journal 599-622 (1999), | http://www.fdli.org/pubs/Journal%20Online/54_4/art8.pdf |
| Stefano Breschi, Francesco Lissoni and Luigi Orsenigo, Success and failure in the development of biotechnology clusters: the case of Lombardy | http://nt-notes.liuc.it/ricerca/IstitutoEconomia.nsf/c6d95ba0f57aa4cac12567b0005a08ba/a13ef9d5ce2843aec1256a14006878de/$FILE/Stuttbook.PDF |
| S. Casper and H. Kettler, National Institutional Frameworks and the Hybridization of Entrepreneurial Business Models: The German and UK Biotechnology Sectors | http://www.unisi.it/epris/abstract/Casper_Kettler.doc |
| John Y. Chai, Medical Device Regulation in the United States and the European Union: A Comparative Study, 55 Food and Drug Law Journal 57-80 (2000), | http://www.fdli.org/pubs/Journal%20Online/55_1/art4.pdf |
| Ian M. Cockburn, Rebecca Henderson and Scott Stern, The Diffusion of Science Driven Drug Discovery: Organizational Change in Pharmaceutical Research, September 1999 | http://www2.cid.harvard.edu/cidbiotech/events/Hend2.pdf |
| Ian Cockburn, Rebecca Henderson and Scott Stern, Balancing Incentives: The Tension Between Basic and Applied Research, August 2000, | http://webuser.bus.umich.edu/departments/busecon/research/papers/BalanceSep00.pdf |
| T.A.B. Corley, The British Pharmaceutical Industry Since 1851 - (33 pages) | http://www.rdg.ac.uk/Econ/Econ/workingpapers/emdp404.pdf |
| H.E. Frech III and Richard D. Miller Jr., The Productivity of Health Care and Pharmaceuticals: An International Comparison, December 1996, -do not quote status- (67 pages) | http://www.econ.ucsb.edu/papers/health.pdf |
| Jeffrey L. Furman, Firm effects vs. Location effects in the organization of pharmaceutical research, January 2001, | http://web.mit.edu/jfurman/www/firm%20v%20industry%20effects%20-%20draft%20Jan01.pdf |
| Alfonso Gambardella, Luigi Orsenigo, Fabio Pammolli, Global Competitiveness in Pharmaceuticals, A European Perspective, , November 2000, report prepared for the Directorate General Enterprise of the European Commission, | http://www.unisi.it/epris/abstract/pdf/pharma.pdf |
| ·GAO - Adverse Events: Surveillance Systems for Adverse Events and Medical Errors, February 2000, | http://www.gao.gov/archive/2000/he00061t.pdf |
| GAO - Attention Disorder Drugs Few Incidents of Diversion or Abuse Identified by Schools, September 2001, | http://www.gao.gov/new.items/d011011.pdf |
| GAO - Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women, January 2001 | http://www.gao.gov/new.items/d01286r.pdf |
| GAO - Human Fetal Tissue: Acquisition for Federally Funded Biomedical Research, October 2000, | http://www.gao.gov/archive/2000/d010065r.pdf |
| GAO - Human Subjects Research: HHS Takes Steps to Strengthen Protections, But Concerns Remain, May 2001 | http://www.gao.gov/new.items/d01775t.pdf |
| GAO - Mutual Recognition Agreement: Update on the Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Good Manufacturing Practice Regulatory Systems, August 1999 | http://161.203.16.4/paprpdf2/162604.pdf |
| GAO - Mutual Recognition Agreement: Food and Drug Administration's Progress in Assessing Equivalency of European Union Pharmaceutical Inspection Programs, February 1999 | http://161.203.16.4/paprpdf2/161744.pdf |
| GAO - NIH Clinical Trials: Various Factors Affect Patient Participation, October 1999 | http://www.gao.gov/archive/1999/he99182.pdf |
| Rebecca Henderson, Luigi Orsenigo, Gary P. Pisano, The Pharmaceutical Industry and the Revolution in Molecular Biology: Exploring the Interactions between Scientific, Institutional and Organizational Change, April 1998, | http://www2.cid.harvard.edu/cidbiotech/events/Hend1.pdf |
| GAO - Women's Health: Women Sufficiently Represented in New Drug Testing, but FDA Oversight Needs Improvement, July 2001, | http://www.gao.gov/new.items/d01754.pdf |
| GAO - ·Women's Health: NIH Has Increased Its Efforts to Include Women in Research, May 2000, | http://www.gao.gov/archive/2000/he00096.pdf |
| GAO - Vaccine Injury Trust Fund: Revenue Exceeds Current Need for Paying Claims, March 2000, | http://www.gao.gov/archive/2000/he00067.pdf |
| GAO - Prescription Drugs, Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs, August 2000, | http://www.gao.gov/archive/2000/he00140.pdf |
| GAO - Prescription Drugs: Drug Company Programs Help Some People Who Lack Coverage, November 2000 | http://www.gao.gov/new.items/d01137.pdf |
| GAO - Pediatric Drug Research: Substantial Increase in Studies of Drugs for Children, But Some Challenges Remain, May 2001, | http://www.gao.gov/new.items/d01705t.pdf |
| William W. Fisher III - Professor of Law, Harvard University Harvard- bioprospecting - Works in Progress - in Legal Reform in Central America (forthcoming, Harvard University Press, 2000) | http://www.law.harvard.edu/Academic_Affairs/coursepages/tfisher/bioprospecting.html |
| Judgment of the Court (Fifth Chamber) of 30 November 1983 - against Leendert van Bennekom - Case 227/82 - Concept of "Medicinal products" | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 7 February 1984. Duphar BV - Case 238/82 - Health-care scheme - Compatibility with the Treaty of restrictions on access to certain medicinal preparations | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court (Fifth Chamber) of 21 March 1991 - against Jean-Marie Delattre -Case C-369/88. - Concepts of "disease" or "illness" and "medicinal product" | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 31 October 1974 - Centrafarm BV et Adriaan de Peijper v Sterling Drug Inc. - Case 15-74 - Reference for a preliminary ruling: Hoge Raad - Netherlands - Parallel patents. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment
of the Court of 20 May 1976 - Adriaan de Peijper, Managing Director of
Centrafarm BV - Case 104-75 Reference for a preliminary ruling: Kantongerecht Rotterdam - Netherlands. |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment
of the Court of 10 October 1978 - Centrafarm BV v American Home Products
Corporation - Case 3/78- Reference for a preliminary ruling:
Arrondissementsrechtbank Rotterdam - Netherlands. Serenid - Seresta. |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 14 July 1981 - Merck & Co. Inc. v Stephar BV and Petrus Stephanus Exler. - Case 187/80 - Reference for a preliminary ruling: Arrondissementsrechtbank Rotterdam - Netherlands. - Patents - Pharmaceutical products. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 18 May 1989 - The Queen v Royal Pharmaceutical Society of Great Britain, ex parte Association of Pharmaceutical Importers and others - Parallel imports - - Trade-mark law - Joined cases 266 and 267/87. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 23 May 1978 - Hoffmann-La Roche & Co. AG v Centrafarm - Case 102/77 - Re-packaging of trade-marked goods. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 9 July 1985 - Pharmon BV v Hoechst AG. - Case 19/84 - Patents - Extent of protection - Exhaustion of patent rights where a compulsory licence has been granted in respect of a parallel patent. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 3 March 1988 - Allen and Hanburys Ltd v Generics (UK) Ltd. - Case 434/85 - Patents endorsed 'Licences of right' - Scope of protection - Compulsory licence under a patent. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 29 November 1983 - Roussel Laboratoria BV - Case 181/82 - Regulation of prices for imported medicines. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 9 June 1988 - Commission of the European Communities v Italian Republic - Case 56/87 - National rules governing the prices of pharmaceutical products. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 19 March 1991 - Commission of the European Communities v Kingdom of Belgium - Case C-249/88 - National legislation on the price of pharmaceutical products - System of programme contracts. | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court of 28 February 1984 - Commission of the European Communities v Federal Republic of Germany - | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of the Court (Fifth Chamber) of 27 May 1986. Société coopérative - Cophalux v Minister for Health - Rules governing the importation and marketing of medicinal products - Joined cases 87 and 88/85 | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment
of the Court (Third Chamber) of 7 March 1989 - Heinz Schumacher v
Hauptzollamt Frankfurt am Main-Ost - Case 215/87 Importation of medicinal preparations |
http://curia.eu.int/common/recdoc/indexaz/en/c1.htm#266/87 |
| Judgment of March 21, 1991 - against Monteil and Samanni - Case 60/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of 16/04/1991, Upjohn / Farzoo - Case 112/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of December 12, 1993 - Pierrel and others / Ministero della Sanità - Case 83/92 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of October 5, 1995 - The Queen / Licensing Authority of the Department of Health and Norgine, ex parte Scotia Pharmaceuticals - Case C-440/93 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (Fifth Chamber) of 3 December 1998 - The Queen v The Licensing Authority established by the Medicines Act 1968 - Case C-368/96 - Marketing authorisation - Abridged procedure - Essentially similar products. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment
of the Court (Fifth Chamber) of 1 July 1993 - Eurim-Pharm GmbH v
Bundesgesundheitsamt. - Case C-207/91. - Parallel imports of pharmaceutical products |
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 12 November 1996 - The Queen v The Medicines Control Agency - Case C-201/94 - Parallel imports - Direct effect of Directive 65/65/EEC - Marketing authorization. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 11 July 1996 - Eurim-Pharm Arzneimittel GmbH v Beiersdorf AG - Case C-71/94 - Repackaging of trade-marked products | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 11 July 1996 - MPA Pharma GmbH v Rhône-Poulenc Pharma GmbH - Case C-232/94- Repackaging of trade-marked products | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 27 October 1992 - Generics (UK) Ltd and Harris Pharmaceuticals Ltd v Smith Kline & French Laboratories Ltd - Case C-191/90 - Compulsory patent licences | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 5 December 1996 - Merck & Co. Inc. -Joined cases C-267/95 and C-268/95 - Parallel imports of unpatentable pharmaceuticals - Spain and Portugal - | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 9 July 1997 - Generics BV v Smith Kline & French Laboratories Ltd. - Case C-316/95- Patent - Registration of medicinal products - Infringement. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Raymond Kohll v Union des caisses de maladie - Case C-158/96- Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 28 April 1998 - Nicolas Decker v Caisse de maladie des employés privés- Case C-120/95 - Reimbursement of medical expenses incurred in another Member State | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment
of the Court (Fifth Chamber) of 10 November 1994 - Lucien Ortscheit GmbH
v Eurim-Pharm Arzneimittel GmbH.-Case C-320/93. - Importation of medicines not agreed by the importing State - Prohibition of advertising |
http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 8 April 1992 - Commission of the European Communities v Federal Republic of Germany -Case C-62/90 - Importation of medicinal products y private individuals - Limits. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court of 8 June 1993 - Commission of the European Communities v Kingdom of Belgium - Case C-373/92 - Obligation to carry out examinations which have already been performed in the Member State of origin. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (Sixth Chamber) of 23 January 1997 - Biogen Inc. v Smithkline Beecham Biologicals SA - Supplementary protection certificate for medicinal products - Refusal by the holder of the marketing authorization- Case C-181/95 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (First Chamber) of 15 May 1997 - Bioforce GmbH v Oberfinanzdirektion München - Case C-405/95 - Common customs tariff - Heading 3004 - Echinacea - Medicament. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| European Union information on the safety of blood | http://europa.eu.int/comm/health/ph/others/safety_blood/index_en.htm |
| The Joint Research Centre - home page - "the European Union’s scientific and technical research laboratory" | http://www.jrc.cec.eu.int/index.asp |
| A European Parliament vote against a ban on human cloning has cleared the way for EU investment in stem cell research over the next five years. | http://europa.eu.int/comm/research/headlines.html#01 |
| Innovation in Europe: Research and Results - Medicine and health | http://europa.eu.int/comm/research/success/en/med/succ-med.html |
| Merger Procedure Abbott / BASF - Case No COMP/M.2312 -REGULATION (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m2312_en.pdf |
| Merger Procedure Pfizer / Warner Lambert - Case No COMP/M.1878 - Regulation (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1878_en.pdf |
| Merger Procedure - Hoechst / Rhône Poulenc - Case No IV//M. 1378 - Regulation EEC n° 4064/89 (55 pages) | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m1378_en.pdf |
| Merger Procedure - Bain / Hoechst-Date Behring - Case No IV/M.954 -Regulation (EEC) No 4064/89 | http://www.europa.eu.int/comm/competition/mergers/cases/decisions/m954_en.pdf |
| A Pharmacist's Guide to Generic Companies - Click on First Letter of Company You are Searching For | http://www.pharmacytimes.com/generic.html |
| WIPO - Patent Protection and Access to HIV / AIDS Phamaceuticals in Sub-Saharan Africa - (105 pages) | http://www.wipo.int/about-ip/en/studies/pdf/iipi_hiv.pdf |
| Pictet Bank -Hepatitis C Therapies - (42 pages) | http://www.pictet.ch/en/services/brokerage/publications/public/sector/hepatitis.pdfdownload.0001.PdfFile0.pdf/Publication%20in%20English.pdf |
| Pictet Bank - Swiss Pharmaceuticals In Perspective - June 2001 - (54 pages) | http://www.pictet.ch/en/services/brokerage/publications/public/sector/swiss11.pdfdownload.0001.PdfFile0.pdf/Publication%20in%20English.pdf |
| Lombard Odier Bank - Drug Delivery: An Emerging Science that helps Patients - November 2001 - (6 pages) | http://www.lombardodier.ch/public/pages/publications_home_en.html#pvi_jc_112001_en.pdf |
| WHO - Globalization and Access to Drugs - Perspectives on the WTO/TRIPS Agreement (111 pages) | http://www.who.int/medicines/library/dap/who-dap-98-9-rev/who-dap-98-9rev.pdf |
| WHO - Globalization, Patents and Drugs: An Annotated Bibliography - 2001 - (64 pages) | http://www.who.int/medicines/library/par/who-edm-par-2001-1/who-edm-par-2001-1.pdf |
| WHO - Health Reform and Drug Financing: Selected Topics - 1998 - (62 pages) | http://www.who.int/medicines/library/dap/who-dap-98-3/who-dap-98-3.pdf |
| WHO - Global Strategy for Containment of Antimicrobial Resistance - 2001 - (105 pages) | http://www.who.int/emc/amrpdfs/WHO_Global_Strategy_English.pdf |
| WHO - Model list of Essential Drugs - (14 pages) | http://www.who.int/medicines/organization/par/edl/edl11.pdf |
| WHO - The definition and selection process for an EDL (essential drug list) - Technical Briefing Paper - 27 October 2000 | http://www.who.int/medicines/organization/par/edl/infedltechbrief.htm |
| WHO - Model Certificate of a Pharmaceutical Product | http://www.who.int/medicines/organization/qsm/activities/drugregul/certification/modcert.html |
| WHO - Guidelines on the implementation of the WHO certification scheme on the quality of pharmaceutical products moving in international commerce | http://www.who.int/medicines/organization/qsm/activities/drugregul/certification/certifguide.html |
| WHO - Achieving balance in national opioids control policy -- Guidelines for assessment - 2000 - (45 pages) | http://www.who.int/medicines/library/qsm/who-edm-qsm-2000-4/Balance%20in%20Nat%20Opioids%20Control%20Policy%20final.pdf |
| WHO - Good Manufacturing Practices | http://www.who.int/medicines/organization/qsm/activities/qualityassurance/gmp/gmpcover.html |
| International Conference on Harmonisation - ICH - home page | http://www.ifpma.org/ich1.html |
| ICH - Harmonisation process | http://www.ifpma.org/ich4.html |
| ICH - list of guidelines | http://www.ifpma.org/ich5.html |
| Executive Committee Meeting in Sorrento 2000 - Summary Report - Patentability Requirements and Scope of Protection of Expressed Sequence Tags (ESTs), Single Nucleotide Polymorphisms (SNPs) and Entire Genomes | http://www.aippi.org/reports/q150/sr-q150-e.htm |
| Drug Benefit Trends - Medscape | http://www.medscape.com/SCP/DBT/public/journal.DBT.html |
| Convention contre le dopage - conclue à Strasbourg le 16 novembre 1989 - entrée en vigueur pour la Suisse le 1er janvier 1993 - RS 0.812.122.1 | http://www.admin.ch/ch/f/rs/i8/0.812.122.1.fr.pdf |
| Accord européen relatif à l’échange de substances thérapeutiques d’origine humaine - conclu à Paris le 15 décembre 1958 - entré en vigueur pour la Suisse le 1er décembre 1965 - RS 0.812.161 | http://www.admin.ch/ch/f/rs/i8/0.812.161.fr.pdf |
| Convention relative à l’élaboration d’une Pharmacopée Européenne - conclue à Strasbourg le 22 juillet 1964 - entrée en vigueur pour la Suisse le 8 mai 19742 - RS 0.812.21 | http://www.admin.ch/ch/f/rs/i8/0.812.21.fr.pdf |
| Kaiser Family Foundation - Generation Rx.com How Young People Use the Internet for Health Information - December 2001 - (45 pages) | http://www.kff.org/content/2001/20011211a/GenerationRx.pdf |
| Kaiser Family Foundation - Understanding the Effects of Direct-to-Consumer Prescription Drug Advertising -November 2001 - (26 pages) | http://www.kff.org/content/2001/3197/DTC%20Ad%20Survey.pdf |
| The Unofficial Gleevec site - home page | http://www.newcmldrug.com/ |
| Gleevec unofficial support web site - home page | http://www.cmlsupport.com/cmlstiresourcecenter.htm |
| Gleevec official web site - home page | http://www.gleevec.com/ |
| OECD - The Economic Aspects of Biotechnologies related to Human Health Part I - 1998 - (72 pages) | http://www1.oecd.org/dsti/sti/s_t/biotech/prod/health.pdf |
| OECD - Working Party on Biotechnology - Economic Aspects of Biotechnologies related to Human Health - 1998 - (269 pages) | http://appli1.oecd.org/olis/1998doc.nsf/4cf568b5b90dad994125671b004bed59/f38277100c7a721bc12566b1006273a6/$FILE/11E88111.ENG |
| OECD - Directorate for Science, Technology and Industry - Committee for Scienttific and Technological Policy - Working Party on Biotechnology - Consultation on Xenotransplantation Surveillance : Summary Report - (51 pages) | http://www.olis.oecd.org/olis/2001doc.nsf/c5ce8ffa41835d64c125685d005300b0/7d4e7b2820d508dfc1256af1005328fc/$FILE/JT00115450.PDF |
| BioAlps | http://www.bioalps.com/ |
| OECD - Why Mice Matter: Novel Systems for the Study of Human Disease from Basic Research to Applications - 1998 - (68 pages) | http://www.oecd.org/pdf/M000014000/M00014633.pdf |
| Jane Wells et al. - Newspaper Reporting of Screening Mammography - Annals of Internal Medicine - December 18, 2001 - Vol. 135 - n° 12 - Pages 1029-1037 | http://www.annals.org/issues/v135n12/abs/200112180-00006.html |
| Kurt Kroenke - Similar Effectiveness of Paroxetine, Fluoxetine, and Sertraline in Primary Care: A Randomized Trial - JAMA - December 19, 2001 - Vol.286, n° 23 - | http://jama.ama-assn.org/issues/v286n23/rfull/joc10747.html |
| Swiss Federal Council - Message concernant la loi fédérale sur la transplantation d’organes, de tissus et de cellules - (227 pages) | http://www.bag.admin.ch/transpla/gesetz/f/BOTSCHAFT_TxG_120901.pdf |
| Federal Council - Message regarding the law on therapeutic products - (108 pages) | http://www.bag.admin.ch/heilmitt/gesetz/f/botsch02.pdf |
| Rapport en vue de la procédure de consultation relative à la Convention sur les droits de l’Homme et la biomédecine - Septembre 1998 - (41 pages) | http://www.ofj.admin.ch/themen/bioeth/vn-ber-f.pdf |
| Council of Europe - CDBI - Projet de Protocole additionnel à la Convention sur les droits de l'Homme et la Biomédecine relatif à la transplantation d'organes et de tissus d'origine humaine et rapport explicatif - February 1999 - (30 pages) | http://www.nfp46.ch/downloads/law/ceprottp99.pdf |
| Council of Europe - Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine | http://conventions.coe.int/treaty/EN/WhatYouWant.asp?NT=164&CM=1&DF=22/03/01 |
| Council
of Europe - Projet de Protocole additionnel à la Convention sur les
Droits de l'Homme et la Biomédecine, relatif à la transplantation d'organes et de tissus d'origine humaine - (9 pages) |
http://www.bag.admin.ch/transpla/inter/f/Draft_PROTOCOL_TRANSP_250701.pdf |
| Amgen - home page | http://www.amgen.com/ |
| Genentech - home page | http://www.gene.com/ |
| Alza - home page | http://www.alza.com/ |
| Genzyme - home page | http://www.genzyme.com/welcome.htm |
| Chiron - home page | http://www.chiron.com/ |
| Johnson & Johnson - home page | http://www.jnj.com/ |
| Cugahi Pharmaceutical - home page - in English | http://www.chugai-pharm.co.jp/ceind02/index.htm |
| Takeda Chemical Industries - home page - in English | http://www.takeda.com/index-e.html |
| Sano-Synthelabo - home page - in English | http://www.sanofi-synthelabo.fr/us/index.asp |
| Kissei Pharmaceutical (Japan) - home page - in English | http://www.kissei.co.jp/e_contents/from_ceo.htm |
| Jomed - home page | http://www.jomed.com/ |
| Fujisawa Pharmaceutical (Japan) - home page - in English | http://www.fujisawa.co.jp/english/index.html |
| WTO - Canada – PATENT PROTECTION OF PHARMACEUTICAL PRODUCTS - Arbitration under Article 21.3(c) of the Understanding on Rules and Procedures - Award of the Arbitrator James Bacchus -August 2000 - (21 pages) | http://www.wto.org/english/tratop_e/dispu_e/114abr_e.pdf |
| WTO
- Canada – Patent Protection of Pharmaceutical products - Complaint by
the European Communities and their member States Report of the panel - (March 2000) - (222 pages) |
http://www.wto.org/english/tratop_e/dispu_e/7428d.pdf |
| Interpharma - Swiss Health Care and Pharmaceutical Market - 2000 - (62 pages) | http://www.interpharma.ch/info/wissens/health_market/pdf/HealthCare00.pdf |
| Interpharma - Swiss Health Care and Pharmaceutical Market - 2001 - (35 pages) | http://www.interpharma.ch/info/wissens/health_market/pdf/HealthCare01-efpia.pdf |
| The Fondation du Présent - home page - "brings together a multisectoral community of over 10,000 members to raise and jointly address health-related issues, particularly HIV/AIDS" | http://www.hivnet.ch/fdp/ |
| Biomedicine - home page - "make Investments in Biotech Companies which are selected according to rigorous scientific and economic criteria" | http://www.biomedicine.ch/index.html |
| 3R Foundation - home page - "to promote alternative research methods to animal experimentation through grants for research projects" | http://www.forschung3r.ch/index_en.html |
| Swiss Federal Veterinary Office - home page | http://www.bvet.admin.ch/0_navigation-e/0_index-intern.html |
| SwissQuote - information about biotechnology companies quoted on the Swiss exchange | http://www.swissquote.ch/research/indexes/index.html |
| Outcome - home page -"support our clients in the pharmaceutical, biotechnology and medical device industries in the launch and commercialization of their products" | http://www.outcomes.ch/index.htm |
| RCC - home page - "provides comprehensive services for the assessment of health and environmental effects of" pharmaceutical products | http://www.rcc.ch |
| Medpoint - home page | http://www.medpoint.ch/ |
| Millenium - home page | http://www.mlnm.com/ |
| IIPI - HIV/AIDS Pilot Project - To Deliver Patented Therapies & Other Treatments to Patients in Developing Countries - | http://www.iipi.org/eng/projects/aids.asp |
| American Bar Association - ABA - Health Law Section | http://www.abanet.org/health/home.html |
| Foundation for Genetic Medicine - home page - examines "a host of issues such as those regarding genetic medicine, behavioral genetics, and the ethical, legal, and social features involved" | http://www.geneticmedicine.org |
| The Committee For the Protection of Human Subjects - homepage - University of California at Berkeley | http://cphs.berkeley.edu:7006/ |
| U.S. Code of Federal Regulations CFR - Title 45 - Public Welfare - Part 46 - Protection of human subjects | http://www.brown.edu/Administration/Research_Administration/OPRR/46index.html |
| Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research - April 18, 1979 | http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm |
| Jeffrey M. Perloff, Valerie Y. Suslow, and Paul J. Seguin - Higher Prices from Entry: Pricing of Brand-Name Drugs - Working Paper No. CPC99-03 - University of California at Berkeley - (39 pages) | http://www.haas.berkeley.edu/groups/cpc/WPs/99-3_are778.pdf |
| Jeanne Clark et al., USPTO - Patent Pools: A Solution to the Problem of Access in Biotechnology Patents? - December 2000 - (17 pages) | http://www.uspto.gov/web/offices/pac/dapp/opla/patentpool.pdf |
| GAO Report - Prescription Drugs: Prices Available Through Discount Cards and From Other Sources - December 5, 2001 - (10 pages) | http://www.gao.gov/new.items/d02280r.pdf |
| Center for Disease Control and Prevention - home page | http://www.cdc.gov/ |
| U.S. Surgeon General - home page | http://www.surgeongeneral.gov/sgoffice.htm |
| U.S. Public Health Service, Report of the Surgeon General’s Conference on Children’s Mental Health: A National Action Agenda. Washington, DC: Department of Health and Human Services, 2000 - (57 pages) | http://www.surgeongeneral.gov/cmh/cmhreport.pdf |
| ATAC - Reference materials on drugs in development and terminology | http://www.atac-usa.org/Pharmanotes.html |
| The Institutional Review Board - Discussion and News Forum - home page | http://www.mcwirb.org/ |
| Tomas Poledna - Medikamentenabgabe durch Ärzte (Selbstdispensation) - Jusletter - January 14, 2001 | http://pdf.weblaw.ch/pdf.asp?ArticleNr=1456&LanguageNr=1 |
| PhRMA - New Drug Approvals in 2001 - January 2002 - (18 pages) | http://www.phrma.org/searchcures/newmeds/resources/2002-01-25.46.pdf |
| US Congress - The Best Pharmaceuticals for Children Act | http://www.fda.gov/cder/pediatric/PL107-109.pdf |
| FDA- International Conference on Harmonization - Public Meeting - Transcripts - 10:30 a.m.- Thursday, January 17, 2002 | http://www.fda.gov/cder/audiences/iact/meeting_transcript_011702.htm |
| The Global Alliance for TB drug development - home page - "Our mission is to accelerate the discovery and/or development of cost-effective new drug" & "not-for-profit, public-private partnership" | http://www.tballiance.org/ |
| The Schneider Institute for Health Policy - Brandeis University - Grant Ritter, Cindy Thomas, and Stanley S. Wallack - Greater Use of Generics: A Prescription for Drug Cost Savings - (17 pages) | http://www.gphaonline.org/pdf/brandeis-text.pdf |
| WHO - Overcoming Antimicrobial Resistance - World Health Report on Infectious Diseases 2000 - February 1, 2002 - (97 pages) | http://www.who.int/infectious-disease-report/2000/other_versions/index-rpt2000_text.html |
| Tom Horton - Patenting our Lives and our Genes: Where does Congress stand in the coming clash? - from FTC web site - (11 pages) | http://www.ftc.gov/os/comments/intelpropertycomments/hortonthomasjarticle.pdf |
| Joint Press Release: Doctors Without Borders/Médecins Sans Frontières (MSF), Treatment Action Campaign (TAC), and Oxfam - Generic AIDS Drugs Offer New Lease on Life to South Africans Importation of Generics Cuts Price in Half | http://www.doctorswithoutborders.org/pr/2002/01-29-2002.shtml |
| GAO - Biomedical Research: HHS Direction Needed to Address Financial Conflicts of Interest - November 2001 - (46 pages) | http://www.gao.gov/new.items/d0289.pdf |
| Task Force on Financial Conflicts of Interest in Clinical Research- Protecting Subjects, Preserving Trust, Promoting Progress– Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research - (25 pages) | http://www.aamc.org/members/coitf/firstreport.pdf |
| Cohen Milstein law firm - Complaint of the GRAY PANTHERS against BRISTOL-MYERS SQUIBB CO., - (25 pages) | http://www.cmht.com/casewatch/cases/buspar.pdf |
| FDA News - home page - "premier provider of domestic and international regulatory, legislative and business news and information for executives in industries regulated by the" FDA | http://www.fdanews.com/index.html |
| Remed - Network for medicines and developpement - home page - "focusing its thinking and action on problems existing in the field of pharmaceuticals in the developing countries" | http://www.remed.org/html/en_welcome.html |
| Pharmabiz - home page - "India's most comprehensive pharma portal" | http://www.pharmabiz.com/ |
| OFAS - Information relative au nouveau système de formation des prix des médicaments - (6 pages) | http://www.bsv.admin.ch/kv/aktuell/f/f_InfoMedi1.pdf |
| Pro-Generika - home page - "le conseiller pour génériques complet" | http://www.pro-generika.ch/indexF.html |
| RVK Rück - "la possibilité de chercher des préparations originales ou génériques de la LS génériques, à partir de deux différentes listes" | http://www.krankenversicherer.ch/index_generika_f.html |
| OFAS - Statistique de l’assurance-maladie 2000 - 2001 - (138 pages) | http://www.bsv.admin.ch/statistik/details/f/kv00f.pdf |
| OFAS - Liste des Spécialités | http://www.bsv.admin.ch/sl/liste/f/index.htm |
| Michal Cohen - Patent Protection of Biotechnological Inventions – Economic Perspectives and the EC Directive Analysis - August 2001 - (63 pages) | http://www.frg.eur.nl/rile/emle/Theses/cohen.pdf |
| Arti K. Rai - THE INFORMATION REVOLUTION REACHES PHARMACEUTICALS: BALANCING INNOVATION INCENTIVES, COST, AND ACCESS IN THE POST-GENOMICS ERA - Draft - Do not Cite or Quote - (44 pages) | http://www.utexas.edu/law/news/colloquium/papers/Raipaper.doc |
| Jean-Marie Kindermans et al. - Changing national malaria treatment protocols in Africa: What is the cost and who will pay? - Case studies: Burundi, Kenya, Rwanda, Tanzania and Uganda - MSF - February 2002 - (14 pages) | http://www.accessmed-msf.org/upload/ReportsandPublications/12220021722584/JMKmalariadoc.pdf |
| Arthur Daemmrich - Invisible Monuments and the Costs of Pharmaceutical Regulation: Twenty-five Years of Drug Lag Debate - Draft essay—do not cite - (25 pages) | http://www.collphyphil.org/druglaghist.pdf |
| Reversal of Fortune? An Assessment of the German Biotechnology Sector in Comparative Perspective - editor: Stephen H. Silvia - Economic Studies Program Series Volume 5 - (60 pages) | http://www.aicgs.org/publications/PDF/biotech.pdf |
| Communication from the European Communities and their Member States to the TRIPS Council - The Relationship Between the Provisions of the TRIPS Agreement and Access to Medicines - Brussels, 13 June 2001 - (5 pages) | http://europa.eu.int/comm/trade/pdf/med_trips.pdf |
| The European Commission - DG Trade - Access to Medicines - Home page | http://europa.eu.int/comm/trade/csc/med.htm |
| Compulsory Licensing under TRIPs and Data Exclusivity - (24 pages) | http://europa.eu.int/comm/trade/pdf/med_lic.pdf |
| John R. Thomas - An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies - Congressional Research Service The Library of Congress - August 31, 2000 - (31 pages) | http://www.cnie.org/nle/crsreports/science/st-60.pdf |
| Judith A. Johnson - Stem Cell Research - Congressional Research Service The Library of Congress -Updated August 10, 2001 - (16 pages) | http://www.cnie.org/nle/crsreports/science/st-68.pdf |
| John Goldsmith - The Exogenous Regulator: Explaining Variation in Time to Approve Generic Drugs - November 2000 - DRAFT Please do not cite or disseminate without permission - (62 pages) | http://www.cramton.umd.edu/workshop/papers/goldsmith-the-exogenous-regulator.pdf |
| GERALD J. MOSSINGHOFF - Overview of the Hatch-Waxman Act and Its Impact on the Drug Development Process - 54 Food and Drug Law Journal 187 (1999) | http://www.fdli.org/pubs/Journal%20Online/54_2/art2.pdf |
| Suresh Koshy - The Effect of TRIPs on Indian Patent Law: A Pharmaceutical Industry Perspective - 1 B.U. J. SCI. & TECH. L. 4. - (27 pages) | http://www.bu.edu/law/scitech/volume1/KOSHY.PDF |
| Sean D. Murphy - Biotechnology and International Law - Social Science Research Network Electronic Paper Collection - (151 pages) | http://papers.ssrn.com/sol3/delivery.cfm/SSRN_ID266470_code010413630.pdf?abstractid=266470 |
| Jean O. Lanjouw - A Patent Policy Proposal for Global Diseases - Yale University, the Brookings Institution and the NBER - April 2001 - (40 pages) | http://econ.worldbank.org/files/1733_lanjouw.pdf |
| Frederick M. Abbott - The TRIPS Agreement, Access to Medicines and the WTO Doha Ministerial Conference - September 8, 2001 - (42 pages) | http://hostings.diplomacy.edu/quaker/new/doc/OP7%20Abbott1.pdf |
| Carsten Fink - How Stronger Patent Protection in India Might Affect the Behavior or Transnational Pharmaceutical Industries - Development Research Group The World Bank - (46 pages) | http://econ.worldbank.org/docs/1106.pdf |
| Philippe Demenet - The high cost of living - Le Monde Diplomatique - February 2002 | http://www.en.monde-diplomatique.fr/2002/02/04stavudine |
| Harvard Forms - Human Subjects Committee | http://www.hsph.harvard.edu/hsc/forms.html |
| The Heritage Foundation - Health Care: Prescription Drugs - list of articles | http://www.heritage.org/library/keyissues/healthcare/drugs.html |
| Commonwealth v. Lanigan, 419 Mass. 15 (1994) - Supreme Judicial Court of Massachusetts, Norfolk. - Argued Sept. 8, 1994. -Decided Nov. 18, 1994. | http://commonwealthpolice.com/2001%20Textbook%20Cases/Commonwealth/CommL/Commonwealth%20v.%20Lanigan,%20419%20Mass.%2015%20(1994).pdf |
| Moore v. Regents of the University of California - 793 P.2d 479 (Cal. 1990) | http://www.richmond.edu/~wolf/moore.htm |
| Diamond v. Chakrabarty, 447 U.S. 303 (1980) | http://www.ipmall.fplc.edu/hosted_resources/jepson/unit3abcd/diamond2.htm |
| ABA - Report of the Sections of Antitrust law and Intellectual property law on the drug competition act of 2001 - (7 pages) | http://www.abanet.org/antitrust/drugcomp.doc |
| Rapport annuel du Surveillant des prix - 2001 - February 2002 - (52 pages) | http://www.monsieur-prix.admin.ch/dynamic/rapport/01_JB/F/Microsoft%20Word%20-%20rapport%20annuel%202001.pdf |
| Swiss National Council - Session d'hiver 2000 - Quatrième séance - November 30, 2000 - Debate on the Law on Therapeutic Products | http://www.parlament.ch/ab/frameset/d/n/4605/22311/d_n_4605_22311_22324.htm?DisplayTextOid=22325 |
| Swiss Senate - Session d'hiver 2000 - Huitième séance - December 7, 2000 - Debate on the Law on Therapeutic Products | http://www.parlament.ch/ab/frameset/d/s/4605/23400/d_s_4605_23400_23404.htm?DisplayTextOid=23405 |
| Senate and National Council, Winter session, 13th session of Winter 2000, December 15, 2000 - Final vote | http://www.parlament.ch/ab/frameset/d/s/4605/25104/d_s_4605_25104_25111.htm?DisplayTextOid=25112 |
| Procédure de consultation relative aux ordonnances d’application afférentes à la loi sur les produits thérapeutiques (LPT) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/orien.pdf |
| List of disagreement between the Swiss Senate and the Swiss National Council, | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/diff.pdf |
| Draft - Ordonnance sur les médicaments (ordonnance sur les médicaments, OMéd) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vam.pdf |
| Rapport explicatif concernant l’ordonnance sur les médicaments OMéd - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vam_erl.pdf |
| Draft
- Ordonnance de l'ISPT sur les exigences relatives à l'autorisation de
mise sur le marché des médicaments (ordonnance sur les exigences relatives aux médicaments, OEMéd) |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/amzv.pdf |
| Draft - Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ambv.pdf |
| Rapport explicatif concernant l’ordonnance sur les autorisations dans le domaine des médicaments - OAMéd - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ambv_erl.pdf |
| Draft - Ordonnance sur les dispositifs médicaux - Odim | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv.pdf |
| FDA, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update | http://www.fda.gov/oc/ohrt/irbs/default.htm |
| OTA, Adverse Reactions to HIV Vaccines: Medical, Ethical, and Legal Issues, September 1995, OTA-BP-H-163 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1995/9524/9524.PDF |
| POMA, Pharmaceutical Outsourcing Management Association, home page | http://www.pomasite.com/ |
| Research Practicioner Journal, home page | http://www.researchpractice.com/ |
| Swiss National Council - Session de printemps 2000 - Sixième séance - 99.020, débat sur la Loi sur les produits thérapeutiques | http://www.parlament.ch/ab/frameset/d/n/4602/9085/d_n_4602_9085_9204.htm |
| Swiss National Council - Session de printemps 2000 - Troisième séance - 08.03.00-08h35, Debate on the Law on Therapeutic products | http://www.parlament.ch/ab/frameset/d/n/4602/8187/d_n_4602_8187_8363.htm |
| Swiss National Council - Session de printemps 2000 - Quatrième séance - 08.03.00-15h00, debate on the Law on Therapeutic products. | http://www.parlament.ch/ab/frameset/d/n/4602/8533/d_n_4602_8533_8534.htm |
| Swiss Senate - Session d'automne 2000 - Septième séance - September 27, 2000 - Debate on the Law on Therapeutic products, | http://www.parlament.ch/ab/frameset/d/s/4604/18863/d_s_4604_18863_18877.htm?DisplayTextOid=18878 |
| Rapport explicatif concernant l’ordonnance sur les dispositifs médicaux - Odim - Project of September 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/mepv_erl.pdf |
| Draft - Ordonnance sur les émoluments de l’Institut suisse des produits thérapeutiques - OE ISPT | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/shi_gebv.pdf |
| Rapport
explicatif concernant l’ordonnance sur les émoluments de l’Institut
suisse des produits thérapeutiques - OE ISPT - Project of September 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/shi_gebv_erl.pdf |
| Procédure de consultation - Projets d’ordonnances sur les produits thérapeutiques (seconde tranche) | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/eroeffnung.pdf |
| Procédure de consultation sur les projets d’ordonnances sur les produits thérapeutiques: Nouvelle numérotation des articles de la loi sur les produits thérapeutiques: adaptation des renvois dans les ordonnances de la première tranche | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/artnum.pdf |
| Draft - Modification de l’ordonnance sur les médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ergaenzungamv.pdf |
| Rapport explicatif concernant la modification de l’ordonnance sur les médicaments - OMéd - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/ergaenzungamv_erl.pdf |
| Draft
- Ordonnance sur l’abrogation et la modification du droit en vigueur
du fait de la loi sur les produits thérapeutiques§ |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vaend.pdf |
| Rapport
explicatif concernant l’ordonnance sur l’abrogation et la
modification du droit en vigueur du fait de la loi sur les produits thérapeutiques - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vaend_erl.pdf |
| Draft - Ordonnance sur la publicité pour les médicaments - OPMéd - | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vawerb.pdf |
| Rapport
explicatif concernant l’ordonnance du Conseil fédéral sur la
publicité pour les médicaments Ordonnance sur la publicité pour les médicaments - OPMéd - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vawerb_erl.pdf |
| Draft - Ordonnance de l’Institut suisse des produits thérapeutiques sur l’autorisation simplifiée de médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza.pdf |
| Rapport
explicatif concernant l’ordonnance de l’Institut suisse des produits
thérapeutiques sur l’autorisation simplifiée de médicaments - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza_erl.pdf |
| Draft - Ordonnance sur les inspections dans le domaine des médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp.pdf |
| Rapport explicatif concernant l’ordonnance sur les inspections dans le domaine des médicaments - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp_erl.pdf |
| Draft - Ordonnance sur les essais cliniques de produits thérapeutiques | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vklinver.pdf |
| Rapport explicatif concernant l’ordonnance sur les essais cliniques de médicaments - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vklinver_erl.pdf |
| FDA - Mifepristone Information (home page) | http://www.fda.gov/cder/drug/infopage/mifepristone/ |
| FDA, CDER, New and Generic Drug Approvals: 1998-2001 | http://www.fda.gov/cder/approval/index.htm |
| FDA, Electronic Orange Book - Approved Drug Products with Therapeutic Equivalence Evaluations (query page) | http://www.fda.gov/cder/ob/default.htm |
| Council for International Organizations of Medical Science ("CIOMS is an international, nongovernmental, non-profit-making organization established jointly by WHO and UNESCO in 1949.") | http://www.cioms.ch/ |
| Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme | http://www.picscheme.org/index.htm |
| European Forum for Good Clinical Practice EFGCP | http://www.efgcp.org/ |
| IMS Health ("the world’s leading provider of information solutions to the pharmaceutical and healthcare industries. ") | http://www.imshealth.com/ |
| Complaint of the State of Montana v. Abbott - February 2002 - (45 pages) | http://www.doj.state.mt.us/ago/newsrel/02releases/BSCComplaint.pdf |
| Complaint of the State of Nevada v. Abbott - January 2002 - (40 pages) | http://ag.state.nv.us/agpress/2002/02_0117a.pdf |
| NERA - Comment on the Interim Wanless Report - Securing Our Future Health: Taking a Long-Term View - January 2002 - (19 pages) | http://www.nera.com/wwt/publications/4974.pdf |
| Agency for Healthcare Research and Quality (AHRQ) - home page | http://www.ahcpr.gov/ |
| Several articles on the history of FDA - Food and Drug Law Journal 50th anniversary Special Issue - 1995 | http://www.fdli.org/pubs/Journal%20Online/jour_toc/vol50_Special.html |
| Stuart L. Nightingale - Challenges in Human Subject Protection - 50 Food and Drug Law Journal 493-501 (1995) - (9 pages) | http://www.fdli.org/pubs/Journal%20Online/50_4/art3.pdf |
| Sheila R. Shulman and Jeffrey S. Brown - The Food and Drug Administration’s Early Access and Fast-Track Approval Initiatives: How Have They Worked? - 50 Food and Drug Law Journal 385-388 (1995) - (29 pages) | http://www.fdli.org/pubs/Journal%20Online/50_4/art4.pdf |
| Jur Strobos - Stoning A Dead Bird: Advertising Limits on Approved New Drugs - 50 Food and Drug Law Journal533-551 (1995) - (19 pages) | http://www.fdli.org/pubs/Journal%20Online/50_4/art5.pdf |
| William Green - Consumer-Directed Advertising of Contraceptive Drugs: The FDA, Depo-Provera, and Product Liability - 50 Food and Drug Law Journal 553-567 (1995) - (15 pages) | http://www.fdli.org/pubs/Journal%20Online/50_4/art6.pdf |
| Lisa A. Foley / Mark D.Whitener - Competition and Antitrust Enforcement in the Changing Pharmaceutical Marketplace - 50 Food and Drug Law Journal 309-312 (1995) - (7 pages) | http://www.fdli.org/pubs/Journal%20Online/50_2/art7.pdf |
| Stephen Paul Mahinka and Kathleen M. Sanzo - Pharmaceutical Industry Restructuring and New Marketing Approaches: Enforcement Responses - 50 Food and Drug Law Journal 313-326 (1995) - (13 pages) | http://www.fdli.org/pubs/Journal%20Online/50_2/art9.pdf |
| William C. MacLeod and J. Howard Beales - Assessments of Pharmaceutical Advertisements: A Critical Analysis of the Criticism - 50 Food and Drug Law Journal 415-449 (1995) - (35 pages) | http://www.fdli.org/pubs/Journal%20Online/50_3/art8.pdf |
| Linda R. Horton - Medical Device Regulation in the European Union - 50 Food and Drug Law Journal 461-476 (1995) - (16 pages) | http://www.fdli.org/pubs/Journal%20Online/50_3/art11.pdf |
| David Woodward - The New Drug Marketing: A Consumer Protection Perspective - 51 Food and Drug Law Journal 637-650 (1996) - (14 pages) | http://www.fdli.org/pubs/Journal%20Online/51_4/art11.pdf |
| Elizabeth C. Price - Teaching the Elephant to Dance: Privatizing the FDA Review Process - 51 Food and Drug law Journal 651-676 (1996) - (26 pages) | http://www.fdli.org/pubs/Journal%20Online/51_4/art12.pdf |
| Marc J. Scheineson - Legal Overview of Likely FDA Regulation of Internet Promotion - 51 Food and Drug Law Journal 697-716 (1996) - (20 pages) | http://www.fdli.org/pubs/Journal%20Online/51_4/art14.pdf |
| Business for Affordable Medicine - home page - "to improve employee access to affordable health care through reform of the federal Hatch-Waxman Act." | http://www.bamcoalition.org/ |
| The Antiretroviral Pregnancy Registry - home page - "intended to provide an early signal of any major teratogenic effect associated with a prenatal exposure to the products monitored through the Registry" | http://www.apregistry.com/ |
| Office of Inspector General (OIG) - Review of Pharmacy Acquisition Costs for Drugs Reimbursed Under the Medicaid Prescription Drug Program of the Montana Department of Public Health and Human Services - February 7, 2002 - (20 pages) | http://oig.hhs.gov/oas/reports/region6/60100005.pdf |
| Amir Attaran - Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health: Options for TRIPS Council - Working draft - (12 pages) | http://www2.cid.harvard.edu/cidwp/087.pdf |
| Speech of Thomas B. Leary - FTC - Antitrust Issues in the Settlement of Pharmaceutical Patent Disputes, Part II | http://www.ftc.gov/speeches/leary/learypharmaceuticalsettlement.htm http://www.ftc.gov/speeches/leary/learypharma.htm |
| Complaint of the FTC Schering-Plough Corporation v. and American Home Products Corporation, | http://www.ftc.gov/os/2001/04/scheringpart3cmp.pdf |
| FTC -Generic Drug Competition: Request for Public Comment on Proposed Commission Information Request to Firms In the Pharmaceutical Industry. - Agency Information Collection Activities; Proposed Collection; Comment Request - Federal Register Notice | http://www.ftc.gov/os/2000/10/frngenericdrugstudy.htm |
| CBO - How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry - July 1998 | http://www.cbo.gov/showdoc.cfm?index=655&sequence=0&from=1 |
| FTC - Memorandum of law - of Amicus Curiae - in opposition to defendant's motion to dismiss -In re: Buspirone Patent Litigation - In re: Buspirone Antitrust Litigation - (37 pages) | http://www.ftc.gov/os/2002/01/busparbrief.pdf |
Last updated: March 29, 2002