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 |
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| 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 |
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| 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 |
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| ICOS - home page - | http://www.icos.com/ |
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| 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 |
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| Roche - home page | http://www.roche.com |
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| 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 |
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| 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 |
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| 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 |
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| 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) |