Marketing authorizations
| Title | Link |
|---|---|
| FDA - CDER - subscribe to mailing lists free of charge. | http://www.fda.gov/cder/cdernew/listserv.html |
| FDA -(proposed) Pediatric Rule - Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients - 21 CFR Parts 201, 312, 314, and 601 - (99 pages) | http://www.fda.gov/cder/guidance/pedrule.pdf |
| US. District Court for the District of Columbia - Memorandum and opinion -October 25, 2001 - (24 pages) | http://www.cei.org/pdfs/pediatric-ruling.pdf |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 - Market Authorisation Withdrawals (Also includes Suspensions of MA) | http://www.emea.eu.int/htms/human/withdraw/withdraw.htm |
| EMEA - CPMP Opinions on approval or refusal of marketing authorizations | http://www.emea.eu.int/htms/human/opinion/opinion.htm |
| 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 |
| Council Directive 93/42/EEC of 14 June 1993 concerning medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1993/en_393L0042.html |
| Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices | http://europa.eu.int/eur-lex/en/lif/dat/1990/en_390L0385.html |
| Swissmedic - form - requête d'autorisation d'exploitation - (fabrication, importation, exportation, commerce, etc.) - (3 pages) | http://www.swissmedic.ch/files/pdf/B3.3.12-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploitation - annexe A - Fabrication de médicaments (manufacture of drugs) - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.3.13-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe B - Importation de médicaments (prêts à l'emploi) (drug imports) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.14-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe C - Commerce de gros de médicaments (drug wholesaler authorization) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.15-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe D - Exportation de médicaments (prêts à l'emploi) (ready-made drug exports) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.16-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe E - Commerce à l'étranger de médicaments (sale of drugs in foreign countries) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.17-f.pdf |
| Swissmedic - form - requête d'autorisation d'exploiter - annexe F - Prélèvement de sang pour la transfusion ou la fabrication de médicaments (blood taking for transfusion / drug manufacturing) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.3.17-f.pdf |
| Swissmedic - form - demande d'autorisation / modification - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.11-f.pdf |
| Swissmedic - form - announce d'effets indésirables suspectés d'un médicament (EI) (possible drug adverse event) - (2 pages) | http://www.swissmedic.ch/files/pdf/B3.2.16_Formulaire_d%27annoce_EI.pdf |
| Swissmedic - form - demande d'octroi d'une autorisation Swissmedic pour médicament à l'expiration de l'enregistrement OICM - (change from IOCM to Swissmedic authorization) (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.96_demande_d%27octroi_%E0_l%27%E9ch%E9ance_d%27enregistrement_OICM-usage_humain.dot |
| Swissmedic - form - statut des demandes d'autorisation déposées à l'étranger | http://www.swissmedic.ch/files/pdf/B3.1.92%20demandes%20d%27autorisation%20d%E9pos%E9e%20%E0%20l%27%E9tranger.doc |
| Swissmedic - form - produit d'origine animale présentant un risque d'EST - (4 pages) | http://www.swissmedic.ch/files/pdf/B3.1.91-f.pdf |
| Swissmedic - form - renseignements concernant les fabricants - (6 pages) | http://www.swissmedic.ch/files/pdf/B3.1.28-f.pdf |
| Swissmedic - list of countries from which imports of drugs in Switzerland are possible (following a simplified procedure) | http://www.swissmedic.ch/overall.asp?theme=0.00107&theme_id=362&nm4prm=cGFnZT0xJmlkPTE5NjM= |
| ICH - Technical Requirements for Registration of Pharmaceuticals for Human Use - ICH M2 EWG Electronic Common Technical Document Specification - 2002 - (160 pages) | http://www.fda.gov/cder/m2/eCTD%20Step%202/eCTD%20Specification%20v2-0-1.pdf |
| FDA - Electronic Common Technical Document FDA Regional Information - (14 pages) | http://www.fda.gov/cder/regulatory/ersr/FDARegional/FDA_regional_eCTD/FDA%20Regional%20-%20Instructions.doc |
| AAC Consulting Group - Audit of Schering-Plough Manufacturing Facility - 2000, (15 pages) | http://www.citizen.org/documents/schering200.pdf |
| Food and Drug Law, Regulation, and Education Global Trends - Issue 2 • April 2000 - (48 pages) | http://www.fdli.org/pubs/Update/2000/issue2.pdf |
| NCAHF (National Council Against Health Fraud ) - Analysis of the Reports of the White House Commission on Complementary and Alternative Medicine Policy (WHCCAMP) | http://www.ncahf.org/whc/00.html |
| White House Commission on Complementary and Alternative Medicine Policy - Final Report -March 2002 | http://www.whccamp.hhs.gov/finalreport.html |
| Public Citizen - Backgrounder Unprecedented Number of Drug Withdrawals Point to Problems in FDA Drug Approval Process | http://www.citizen.org/congress/regulations/issue_areas/drug_devise/articles.cfm?ID=7442 |
| FY 2001 Performance Report to Congress for the Prescription Drug User Fee Act of 1992 as reauthorized and amended by the Food and Drug Administration Modernization Act of 1997 | http://www.fda.gov/oc/pdufa/report2001/pdufareport.html |
| Holly Aprea - FDA Regulation of Tobacco A Closer Look at the Forces Contributing to the Movement for Regulation - 2001 - (118 pages) | http://www.american.edu/academic.depts/honors/CurrentStudents/capstones/aprea.pdf |
| Chrisanthi Avgerou, Tony Cornford and Elias Mossialos - Drug Use Information Systems: A European Perspective, August 1995.- (26 pages) | http://www.lse.ac.uk/Depts/lsehsc/papers/Discussion_Papers/dp2.pdf |
| U.S. Supreme Court decision - FDA v. Brown & Williamson Tobacco Corp. (98-1152) 153 F.3d 155, affirmed. (39 pages & 32 pages) - tobacco as a drug/device | http://supct.law.cornell.edu/supct/pdf/98-1152P.ZO http://supct.law.cornell.edu/supct/pdf/98-1152P.ZD |
| Pharmaceuticals in the European Union - booklet - (31 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/brochurenov99.pdf |
| FDA Backgrounder - FDA's Budget Request for FY 2002 | http://www.fda.gov/opacom/backgrounders/budget.html |
| FDA - Milestones in U.S. Food and Drug Law History | http://www.fda.gov/opacom/backgrounders/miles.html |
| FDA- FY 2002 Congressional Budget Request - Various documents | http://www.fda.gov/oc/oms/ofm/budget/2002/2002budget.htm |
| JAAC 59.34 -Décision de la Commission fédérale de recours en matière de douanes du 27 octobre 1994 - Capsules Y | http://www.vpb.admin.ch/franz/doc/59/59.34.html |
| FDA - CDER Manual of Policies and Procedures MaPPs | http://www.fda.gov/cder/mapp.htm |
| Procedure on the granting of marketing authorisations by central and Eastern European Countries for medicinal products for human use - December 1999 - (18 pages) | http://www.il.waw.pl/centralised_procedure.pdf |
| Note for Guidance on Specifications: test procedures and acceptance criteria for biotechnological/biological products - (17 pages) | http://www.emea.eu.int/pdfs/human/ich/036596en.pdf |
| Note for Guidance on Specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products - (19 pages) | http://www.emea.eu.int/pdfs/human/qwp/282000en.pdf |
| FDA - Notice - Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000and 2002 | http://www.fda.gov/cber/genadmin/fr-estab.pdf http://www.pharmcast.com/FederalRegistrar/Yr2002/011402/UserFee011602.htm |
| 21 CFR (Code of Federal Regulations) Parts 210 and 211 Part 210 - Current Good Manufacturing Practice | http://www.fda.gov/cder/dmpq/cgmpregs.htm |
| FDA - Main page on Good Manufacturing Practices | http://www.fda.gov/cder/dmpq/index.htm |
| FDA - Compliance Program Guidance Manual for FDA Staff: Drug Manufacturing Inspections | http://www.fda.gov/cder/dmpq/compliance_guide.htm |
| Report of the Committee on the Drug Review Process of the Science Advisory Board to Health Canada - (17 pages) | http://www.hc-sc.gc.ca/hpb/science/pdf/drg/drug_e.pdf |
| EMA - Annual Report 2001 - (72 pages) | http://www.emea.eu.int/pdfs/general/direct/emeaar/005201en.pdf |
| Global Market Liberalization, Mutual Recognition Agreements, and Industry Standards: International Competition, Regulatory Cooperation, and Consumer Protection in North America and Europe -(165 pages) | http://transatlantic.gwu.edu/~tranconf/publication.pdf |
| Joshua T. Cohen Keith Duggar George M. Gray Silvia Kreindel - Evaluation of the Potential for Bovine Spongiform Encephalopathy in the United States - Harvard Center for Risk Analysis Harvard School of Public Health - (127 pages) | http://www.aphis.usda.gov/oa/bse/mainreporttext.pdf http://www.fda.gov/oc/bse/harvard_study.html |
| FDA - A Trial of St. John's Wort (Hypericum perforatum) for the Treatment of Major Depression | http://nccam.nih.gov/ne/press-releases/stjohnswort/q-and-a.htm |
| FDA - Medication Guide Accutane Capsules (isotretinoin) | http://www.fda.gov/cder/drug/infopage/accutane/medicationguide.htm#important warnings |
| A National Survey of Oncologists Regarding The Food and Drug Administration Conducted by the polling company for the Competitive Enterprise Institute (CEI) - (12 pages) | http://www.cei.org/pdf/2987.pdf |
| Barsky AJ, Saintfort R, Rogers MP, Borus JF. Nonspecific medication side effects and the nocebo phenomenon. JAMA. 2002;287:622-627 - (6 pages) | http://jama.ama-assn.org/issues/v287n5/rpdf/jsc10377.pdf |
| Center for Drug Evaluation and Research - 2001 Report to the Nation - Improving Public Health Through Human Drugs - (50 pages) | http://www.fda.gov/cder/reports/rtn/2001/rtn2001.pdf |
| FDA - 2002 Workshop on Pharmacogenetics / Pharmacogenomics in Drug Development and Regulatory Decision-Making - May 16-17th, 2002 - (65 pages) | http://www.fda.gov/cder/calendar/meeting/phrma52002/workbook.pdf |
| Investigators' Reports Maker of Growth Hormone Feels Long Arm of Law - FDA Consumer magazine September-October 1999 | http://www.fda.gov/fdac/departs/1999/599_irs.html |
| FDA - Rule - New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible | http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0237-nfr0001-vol1.pdf |
| JAAC 66.16 Décision de la Commission fédérale de recours en matière d'alcool - August 20, 2001 | http://www.vpb.admin.ch/franz/contenu_fr.html |
| Proposal for a Regulation and Directive - laying down Community procedures for the authorisation and supervision of medicinal products for human use - November 2001 - (200 pages) | http://pharmacos.eudra.org/F2/review/doc/finaltext/011126-COM_2001_404-EN.pdf |
| ICH M2 EWG Electronic Common Technical Document Specification- Technical Requirements for registration of pharmaceuticals for human use - February 12, 2002 - (160 pages) | http://www.fda.gov/cder/guidance/5017dft.pdf |
| ICH Q1E - Draft Consensus Guideline Evaluation of Stability Data - 7 February 2002 | http://www.fda.gov/cder/guidance/4983dft.pdf |
| ICH Q1F Draft Consensus Guideline - Stability Data Package for Registration in Climatic Zones III and IV - February 7, 2002 - (5 pages) | http://www.fda.gov/cder/guidance/4984dft.pdf |
| Swissmedic - Guide to the regulation of medical devices | http://www.swissmedic.ch/md/files/leitf-e.html |
| OTA - Drug Labeling in Developing Countries - 1993 | http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9321/9321.PDF |
| The National Organization for the Reform of Marijuana Laws - home page | http://www.norml.org/ |
| Rapport sur le Cannabis de la Commission fédérale pour les questions liées aux drogues - CFLD - Septembre 1999 - (114 pages) | http://www.bag.admin.ch/sucht/publikationen/f/cannabis.pdf |
| FDA - Guidance for Industry Providing Regulatory Submissions in Electronic Format — ANDAs - (10 pages) | http://www.fda.gov/cder/guidance/5004fnl.pdf |
| Ordonnance de l'OFSP du 8 novembre 1996 sur les précurseurs et autres produits chimiques utilisés pour la fabrication de stupéfiants et de substances psychotropes (Ordonnance de l'OFSP sur les précurseurs, O Prec-OFSP) | http://www.admin.ch/ch/f/rs/8/812.121.31.fr.pdf |
| Ordonnance du 8 mars 1999 sur la prescription médicale d'héroïn | http://www.admin.ch/ch/f/rs/8/812.121.6.fr.pdf |
| Loi fédérale du 21 mars 1969 sur le commerce des toxiques (Loi sur les toxiques | http://www.admin.ch/ch/f/rs/8/813.0.fr.pdf |
| Ordonnance du 19 septembre 1983 sur les toxiques (Otox) | http://www.admin.ch/ch/f/rs/8/813.01.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 |
| Loi fédérale du 9 octobre 1992 sur les denrées alimentaires et les objets usuels (loi sur les denrées alimentaires, LDAI); RS 817.0 | http://www.admin.ch/ch/f/rs/8/817.0.fr.pdf |
| Ordonnance du 1 er mars 1995 sur les denrées alimentaires (ODAI); RS 817.02 | http://www.admin.ch/ch/f/rs/8/817.02.fr.pdf |
| Ordonnance du 26 juin 1995 sur les additifs admis dans les denrées alimentaires (O sur les additifs, OAdd); RS 817.021.22 | http://www.admin.ch/ch/f/rs/8/817.021.22.fr.pdf |
| Ordonnance du 26 juin 1995 sur les substances étrangères et les composants dans les denrées alimentaires (O sur les substances étrangères et les composants, OSEC); RS 817.021.23 | http://www.admin.ch/ch/f/rs/8/817.021.23.fr.pdf |
| Ordonnance du 19 novembre 1996 concernant la procédure d'autorisation relative aux denrées alimentaires OGM, aux additifs OGM et aux auxiliaires technologiques OGM (OAOGM); RS 817.021.35 | http://www.admin.ch/ch/f/rs/8/817.021.35.fr.pdf |
| Ordonnance du 6 mars 2000 sur l'indication du pays de production des denrées alimentaires, des additifs alimentaires et des matières premières (Ordonnance sur l’indication de la provenance des matières de base, OIPMB); RS 817.021.51. | http://www.admin.ch/ch/f/rs/8/817.021.51.fr.pdf |
| Ordonnance du 26 juin 1995 sur la valeur nutritive (ONutr); RS 817.021.55. | http://www.admin.ch/ch/f/rs/8/817.021.55.fr.pdf |
| Ordonnance du 1er mars 1995 sur les objets usuels (OUs); RS 817.04 | http://www.admin.ch/ch/f/rs/8/817.04.fr.pdf |
| Ordonnance du 26 juin 1995 sur les cosmétiques (OCos); RS 817.042.1 | http://www.admin.ch/ch/f/rs/8/817.042.1.fr.pdf |
| 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 3 octobre 1951 sur les stupéfiants et les substances psychotropes (Loi sur les stupéfiants, LStup | http://www.admin.ch/ch/f/rs/8/812.121.fr.pdf |
| Ordonnance du 29 mai 1996 sur les stupéfiants et les substances psychotropes (Ordonnance sur les stupéfiants, Ostup) | http://www.admin.ch/ch/f/rs/8/812.121.1.fr.pdf |
| Ordonnance de l'OFSP du 12 décembre 1996 sur les stupéfiants et les substances psychotropes (Ordonnance de l'OFSP sur les stupéfiants, Ostup-OFSP) | http://www.admin.ch/ch/f/rs/8/812.121.2.fr.pdf |
| Ordonnance du 29 mai 1996 sur les précurseurs et autres produits chimiques utilisés pour la fabrication de stupéfiants et de substances psychotropes (Ordonnance sur les précurseurs, OPrec) | http://www.admin.ch/ch/f/rs/8/812.121.3.fr.pdf |
| Ordonnance du 1er mars 1995 sur le tabac et les produits du tabac (O sur le tabac, OTab); RS 817.06 | http://www.admin.ch/ch/f/rs/8/817.06.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 |
| ATF 127 IV 178 - Decision of the Swiss Federal Tribunal - regarding hallucinogen mushrooms - July 4, 2001 - | http://www.eurospider.ch/buge3/index/127_IV.html |
| 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 |
| Convention du 8 octobre 1970 pour la reconnaissance mutuelle des inspections concernant la fabrication des produits pharmaceutiques (avec notes explicatives); RS 0.812.101 | http://www.admin.ch/ch/f/rs/i8/0.812.101.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/reviewrapport/rap_fv_en.pdf |
| 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/2codehumain_fr_18-7-2001.pdf |
| Reform of EU Pharmaceutical Legislation, Brussels, 18 July 2001, MEMO/01/267 | http://pharmacos.eudra.org/F2/review/doc/brief_m01_267_en.pdf |
| List of directives and regulations of the European Union regarding proprietary medicinal products | http://europa.eu.int/eur-lex/en/lif/reg/en_register_1530.html |
| 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 |
| 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 - (46 pages) | http://www.fda.gov/cder/reports/RTN2000/RTN2000.PDF |
| 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 |
| FDA Center for Food Safety and Applied Nutrition, Cosmetic Handbook | http://www.cfsan.fda.gov/~dms/cos-hdbk.html |
| Home Page of the FDA Center for Food Safety & Applied Nutrition | http://www.cfsan.fda.gov |
| Home Page of the FDA Center for Food Safety & Applied Nutrition regarding cosmetics | http://vm.cfsan.fda.gov/~dms/cos-toc.html |
| 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.pdf |
| 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/f/vern_ber.pdf |
| 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/# |
| 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 |
| 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 |
| 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 |
| 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 |
| Federal Council, Message concernant la loi fédérale sur la protection contre les substances et les préparations dangereuses (Loi sur les produits chimiques, LChim) du 24 novembre 1999 - FF 2000 623 - (161 pages) | http://www.admin.ch/ch/f/ff/2000/623.pdf |
| Draft - Loi fédérale sur la protection contre les substances et les préparations dangereuses (Loi sur les produits chimiques, LChim) - FF 200 784 - (22 pages) | http://www.admin.ch/ch/f/ff/2000/784.pdf |
| 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 of June 14, 2001, 6S.15/2001/vlc regarding marijuane and hachisch | http://wwwsrv.bger.ch/cgi-bin/AZA/MapProcessorCGI_AZA?mapfile=pull/ConvertDocFrameCGI.map&ri=fr&lang=fr&ds=AZA_pull&d=14.06.2001_6S.15%2f2001&pa=2%7eoicm%4010%7eoicm%404%7e& |
| 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 |
| Medical Devices Ordinance (MDO) Information on Article 13 Reporting of serious incidents | http://www.bag.admin.ch/md/pdf/VI-Indus-InfoE.pdf |
| European Committee for Standardization - CEN - home page | http://www.cenorm.be/ |
| 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 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 - 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 - Tissue Related Documents | http://www.fda.gov/cber/tissue/docs.htm |
| 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 |
| ATF 99 Ia 370 - decision of the Swiss Federal Tribunal regarding sale by Migro of Vitamins C | http://www.eurospider.ch/buge3/index/99_I.html |
| ATF 127 II 91 - decision of the Swiss Federal Tribunal regarding an advertisement for milk as preventing osteoporose | http://www.eurospider.ch/buge3/index/127_II.html |
| PERF - Pan European Regulatory Forum - home page - "The ultimate aim of this programme is the transposition of all technical regulations and European technical acts into the national legislation of central and eastern European countries (CEECs)" | http://perf.eudra.org/ |
| European Commission - Pharmaceuticals in the European Union - Information brochure - (42 pages) | http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/pharmaeu.pdf |
| 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 |
| 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 |
| 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 |
| GAO - Dietary Supplements: Uncertainties in Analyses Underlying FDA's Proposed Rule on Ephedrine Alkaloids, July 1999, | http://www.gao.gov/archive/1999/h299090.pdf |
| GAO - Drug Safety: Most Drugs Withdrawn in Recent Years Had Greater Health Risks for Women, January 2001 | http://www.gao.gov/new.items/d01286r.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 - Prescription Drugs, Many Factors Affected FDA's Approval of Selected 'Pipeline' Drugs, August 2000, | http://www.gao.gov/archive/2000/he00140.pdf |
| Judgment of the Court (Fifth Chamber) of 30 November 1983 - against Leendert van Bennekom - Case 227/82 - Concept of "Medicinal products" | http://curia.eu.int/common/recdoc/indexaz/en/c1.htm |
| Judgment of the Court of 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 March 21, 1991 - against Monteil and Samanni - Case 60/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of 16/04/1991, Upjohn / Farzoo - Case 112/89 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of May 20, 1992 - Commission / Germany - Case 290/90 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of December 12, 1993 - Pierrel and others / Ministero della Sanità - Case 83/92 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of October 5, 1995 - The Queen / Licensing Authority of the Department of Health and Norgine, ex parte Scotia Pharmaceuticals - Case C-440/93 | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment of the Court (Fifth Chamber) of 3 December 1998 - The Queen v The Licensing Authority established by the Medicines Act 1968 - Case C-368/96 - Marketing authorisation - Abridged procedure - Essentially similar products. | http://curia.eu.int/common/recdoc/indexaz/en/c2.htm |
| Judgment
of the Court (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 (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 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 (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 |
| WHO - Herbal medicines - Assessment of safety and efficacy | http://www.who.int/medicines/library/trm/medicinalplants/assessdocs.shtml |
| WHO - Acupuncture | http://www.who.int/medicines/library/trm/acupuncture/acupdocs.shtml |
| WHO - 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 |
| 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 |
| Federal Council - Message regarding the law on therapeutic products - (108 pages) | http://www.bag.admin.ch/heilmitt/gesetz/f/botsch02.pdf |
| 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 |
| PhRMA - New Drug Approvals in 2001 - January 2002 - (18 pages) | http://www.phrma.org/searchcures/newmeds/resources/2002-01-25.46.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 |
| 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 |
| 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 |
| 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 - 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 de l’Institut suisse des produits thérapeutiques sur l’autorisation simplifiée de médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza.pdf |
| Rapport
explicatif concernant l’ordonnance de l’Institut suisse des produits
thérapeutiques sur l’autorisation simplifiée de médicaments - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vvza_erl.pdf |
| Draft - Ordonnance de l’Institut suisse des produits thérapeutiques sur la mise sur le marché des médicaments homéopathiques et des médicaments anthroposophiques sans indications | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vhom.pdf |
| Rapport
explicatif concernant l’ordonnance de l’Institut suisse des produits
thérapeutiques sur la mise sur le marché des médicaments homéopathiques et des médicaments anthroposophiques sans indications - Project of December 2000 |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vhom_erl.pdf |
| Draft - Ordonnance sur les inspections dans le domaine des médicaments | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp.pdf |
| Rapport explicatif concernant l’ordonnance sur les inspections dans le domaine des médicaments - Project of December 2000 | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/vinsp_erl.pdf |
| Rapport
explicatif concernant le projet de modification de - l’ordonnance du
29 mai 1996 sur les stupéfiants et les substances psychotropes - Ostup - et de l' ordonnance sur les précurseurs - Opréc |
http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendbetm_erl.pdf |
| Draft -Ordonnance sur les stupéfiants et les substances psychotropes | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendbetm.pdf |
| Draft - Ordonnance sur les précurseurs et autres produits chimiques utilisés pour la fabrication des stupéfiants et de substances psychotropes | http://www.bag.admin.ch/heilmitt/gesetz/verord/f/aendvorlv.pdf |
| FDA - Mifepristone Information (home page) | http://www.fda.gov/cder/drug/infopage/mifepristone/ |
| FDA, CDER, New and Generic Drug Approvals: 1998-2001 | http://www.fda.gov/cder/approval/index.htm |
| Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme | http://www.picscheme.org/index.htm |
| 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 |
| 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 |
| Stephen H. McNamara - Dietary Supplements of Botanicals and Other Substances: A New Era of Regulation - 50 Food and Drug Law Journal341-348 (1995) - (8 pages) | http://www.fdli.org/pubs/Journal%20Online/50_3/art1.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 |
| 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 |