FDA
| Title | Link |
|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| FDA - Office of Medical Policy - Division of Drug Marketing, Advertising, and Communications - Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs Main Survey Results | http://www.fda.gov/cder/ddmac/dtcindex.htm http://www.fda.gov/cder/ddmac/dtcfllw.htm |
| FDA - Division of Drug Marketing, Advertising, and Communications National Surveys of Prescription Medicine Information Received by Consumers | http://www.fda.gov/cder/ddmac/Y2KTITLE.HTM |
| FDA - Evaluation of Written Prescription Information Provided in Community Pharmacies: An 8-State Study | http://www.fda.gov/cder/calendar/meeting/rx2000/report1.htm |
| FDA - Center for Drug Evaluation and Research - Transcript of a Public Meeting: Current Status of useful written Prescription Drug Information for Patients, Volumes I and II - February 29, 2000 | http://www.fda.gov/cder/ddmac/tranvol1.htm http://www.fda.gov/cder/ddmac/tranvol2.htm |
| FDA - Guidance for Industry Consumer-Directed Broadcast Advertisements - (6 pages) | http://www.fda.gov/cder/guidance/1804fnl.pdf |
| FDA - Guidance for Industry - Industry-Supported Scientific and Educational Activities | http://www.fda.gov/cder/guidance/isse.pdf |
| FDA - Guidance for Industry - Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling - Draft Guidance - (8 pages) | http://www.fda.gov/cder/guidance/1955dft.pdf |
| FDA - Draft Guidance for Industry - Promoting Medical Products in a Changing Healthcare Environment; I. Medical Product Promotion by Healthcare Organizations or Pharmacy Benefits Management Companies (PBMs) - (6 pages) | http://www.fda.gov/cder/guidance/1726dft.pdf |
| FDA - Guidance for Industry Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements - (7 pages) | http://www.fda.gov/cder/guidance/4114dft.pdf |
| FDA - Guidance List - (31 pages) | http://www.fda.gov/cder/guidance/guidlist.pdf |
| FDA - Electronic Common Technical Document FDA Regional Information - (14 pages) | http://www.fda.gov/cder/regulatory/ersr/FDARegional/FDA_regional_eCTD/FDA%20Regional%20-%20Instructions.doc |
| FDA - Use of Placebo controls in developing countries - (13 pages) | http://www.citizen.org/documents/1558attachment.pdf |
| 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 |
| The Pediatric Exclusivity Provision - January 2001- Status Report to Congress - (57 pages) | http://www.fda.gov/cder/pediatric/reportcong01.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 |
| FDA - CDER Manual of Policies and Procedures MaPPs | http://www.fda.gov/cder/mapp.htm |
| FDA - Notice - Establishment of Prescription Drug User Fee Rates for Fiscal Year 2000and 2002 | http://www.fda.gov/cber/genadmin/fr-estab.pdf http://www.pharmcast.com/FederalRegistrar/Yr2002/011402/UserFee011602.htm |
| FDA - Cyber Letters 2000/2001/2002 | http://www.fda.gov/cder/warn/cyber/cyber2000.htm http://www.fda.gov/cder/warn/cyber/cyber2001.htm http://www.fda.gov/cder/warn/cyber/cyber2002.htm |
| 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 |
| FDA - Guidance Financial Disclosure by Clinical Investigators | http://www.fda.gov/oc/guidance/financialdis.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 |
| FDA - Division of Drug Marketing, Advertising, and Communications - Attitudes and Behaviors Associated with Direct-to-Consumer (DTC) Promotion of Prescription Drugs Main Survey Results | http://www.fda.gov/cder/ddmac/dtcindex.htm http://www.fda.gov/cder/ddmac/dtcfllw.htm |
| 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 |
| FDA - Inspection report of Abbott Laboratories (3 pages) | http://www.citizen.org/documents/1619appendix.pdf |
| Draft - FDA Guidance for Industry on: Exports and Imports Under the FDA Export Reform and Enhancement Act of 1996 - February 1998 | http://www.fda.gov/opacom/fedregister/frexport.html |
| Investigators' Reports Maker of Growth Hormone Feels Long Arm of Law - FDA Consumer magazine September-October 1999 | http://www.fda.gov/fdac/departs/1999/599_irs.html |
| Tamar Nordenberg - Direct to You: TV Drug Ads That Make Sense - FDA Consumer magazine - January- February 1998 | http://www.fda.gov/fdac/features/1998/198_ads.html |
| FDA Guidance for Industry Consumer-Directed Broadcast Advertisements Questions and Answers | http://www.fda.gov/cder/guidance/1804q&a.htm |
| FDA - Rule - New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible | http://www.fda.gov/OHRMS/DOCKETS/98fr/98n-0237-nfr0001-vol1.pdf |
| Final Report - Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001 | http://www.fda.gov/cder/reports/prescriptionInfo/default.htm |
| 3 Warning Letters on Good Laboratory Practices | http://www.fda.gov/foi/warning_letters/g1990d.pdf http://www.fda.gov/foi/warning_letters/g1864d.pdf http://www.fda.gov/foi/warning_letters/g2044d.pdf |
| FDA - Guidance for Industry Prescription Drug Marketing Act Regulations for Donation of Prescription Drug Samples to Free Clinics - (7 pages) | http://www.fda.gov/cder/guidance/4932dft.PDF |
| FDA - Guidance for Industry Providing Regulatory Submissions in Electronic Format — ANDAs - (10 pages) | http://www.fda.gov/cder/guidance/5004fnl.pdf |
| Isadora Stehlin, Homeopathy: Real Medicine or Empty Promises? FDA Consumer magazine (December 1996). | http://www.fda.gov/fdac/features/096_home.html |
| U.S. Federal Drug and Food Administration - FDA - home page | http://www.fda.gov/guidance |
| 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 |
| FDA, Acupuncture needle status changed - April 1, 1996 | http://www.fda.gov/bbs/topics/ANSWERS/ANS00722.html |
| 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 - Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified CornJune 11, 2001 - (24 pages) | http://www.cdc.gov/nceh/ehhe/Cry9cReport/cry9creport.pdf |
| FDA - FDA documents concerning StarLink | http://www.epa.gov/scipoly/sap/index.htm#july |
| FDA - Food and Cosmetic Guidance Documents | http://www.cfsan.fda.gov/~dms/guidance.html |
| FDA - Guidance for Industry - Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements | http://www.cfsan.fda.gov/~dms/ssaguide.html |
| FDA - Draft - Guidance for Industry - Voluntary Labeling Indicating Whether Foods Have or Have Not Been Developed Using Bioengineering - January 2001 | http://www.cfsan.fda.gov/~dms/biolabgu.html |
| FDA - Report on Consumer Focus Groups on Biotechnology | http://www.cfsan.fda.gov/~comm/biorpt.html |
| FDA - Food and Cosmetics International Activities | http://www.cfsan.fda.gov/~comm/intl-toc.html |
| FDA - A New Kind of Fish Story: The Coming of Biotech Animals - FDA Magazine - January February 2001 | http://www.cfsan.fda.gov/~dms/fdbiofsh.html |
| FDA - Dietary supplements - home page | http://www.cfsan.fda.gov/~dms/supplmnt.html |
| FDA - Overview of Dietary Supplements - FAQs | http://www.cfsan.fda.gov/~dms/supplmnt.html |
| FDA - Claims That Can Be Made for Conventional Foods and Dietary Supplements | http://www.cfsan.fda.gov/~dms/hclaims.html |
| FDA - A Food Labeling Guide--Appendix C | http://www.cfsan.fda.gov/~dms/flg-6c.html |
| FDA - CFR 21 § 101.72 - Health claims: calcium and osteoporosis. | http://www.cfsan.fda.gov/~lrd/cf101-72.html |
| 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 |
| FDA - Food Labeling; Health Claims and Label Statements for Dietary Supplements - Strategy for Implementation of Pearson Court Decision | http://www.fda.gov/ohrms/dockets/98fr/120199b.pdf |
| 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 |
| 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 |
| FDA, Guidance for Institutional Review Boards and Clinical Investigators, 1998 Update | http://www.fda.gov/oc/ohrt/irbs/default.htm |
| 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 |
| FDA, Warning Letters (home page) | http://www.fda.gov/foi/warning.htm |
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Last updated: July 7, 2002