Source: http://www.circare.org/info5.htm
Timestamp: 2017-03-25 11:32:35
Document Index: 86018538

Matched Legal Cases: ['art 50', 'art=50', 'art 54', 'art=54', 'art 56', 'art=56', 'art 312', 'art=312', 'art 812', 'art=812']

FDA Research Regulations and Information
2012-10-26: we appreciate your patience while we update this page following recent changes on the FDA website. What information is available on this page? FDA Division of Scientific Investigations (DSI), Bioresearch Monitoring Information System (BMIS), CDER and CBER Clinical Investigator Inspection Lists FDA Division of Scientific Investigations (DSI): Warning Letters and Administrative Actions FDA FOIA Electronic Reading Rooms
Institutional Review Boards — Restrictions Imposed Letters FDA Guidance Documents and Good Clinical Practice Information (FDA Information Sheet Guidances, Guidance for Institutional Review Boards and Clinical Investigators, Frequently Asked Questions is generally accessible to non-professionals.) FDA and Federal Regulations for Research FDA Dockets: General Information and Docket Entries Related to Research and Human Research Protections FDA Information Resources: Publications and Databases FDA Advisory Committee Information FDA Office of Regulatory Affairs: Office of Criminal Investigations (OCI) FDA Errata: Unusual, Interesting, and Hard to Find FDA Information FDA History What information is available elsewhere on the CIRCARE web site? You can find less technical information about participating in FDA-regulated research, including a small selection of basic brochures, at our index of resources for research subjects and people considering participating in research: http://www.circare.org/subjects/startpage.htm Concerns / Complaints About FDA-Regulated Research (including FDA contact information): http://www.circare.org/subjects/studycomplaint.htm FDA Medical Device Regulations and Information: http://www.circare.org/info/device.htm Drug Information Page (under construction 2006-09-18): http://www.circare.org/info/drugs.htm Complaints / Concerns About FDA-Regulated Products (Drugs, Medical Devices, Dietary Supplements, and Food): http://www.circare.org/info/productcomplaint.htm DHHS / Office for Human Research Protections / Regulation of Federally-Funded Research (The Common Rule, 45 CFR 46): http://www.circare.org/info5a.htm Children in Federally Regulated Research (FDA and DHHS): http://www.circare.org/info/pediatric.htm HELP! I can't find what I'm looking for! FDA Division of Scientific Investigations
FDA Bioresearch Monitoring Information System (BMIS) - Find information about clinical investigators and IRBs in drug studies for IND applications: Bioresearch Monitoring Information System File Search: http://www.accessdata.fda.gov/scripts/cder/bmis/index.cfm Bioresearch Monitoring Information System File Advanced Search: http://www.accessdata.fda.gov/scripts/cder/BMIS/index.cfm?fuseaction=Search.ShowAdvancedSearchForm Bioresearch Monitoring Information System File for Download (NB enormous file sizes; data files must be imported into a database program like Microsoft Access® or FileMaker Pro®): http://www.fda.gov/Drugs/InformationOnDrugs/ucm135162.htm Bioresearch Monitoring Information System File Database Field Definitions and Information (what the data mean): http://www.fda.gov/Drugs/InformationOnDrugs/ucm135162.htm FDA Center for Drug Evaluation and Research (CDER) Clinical Investigator Inspection List (CLIIL) – Find information about FDA inspections of Clinical Investigators conducting drug studies for IND applications: Clinical Investigator Inspection List Search: http://www.accessdata.fda.gov/scripts/cder/cliil/ Clinical Investigator Inspection List Advanced Search: http://www.accessdata.fda.gov/scripts/cder/CLIIL/index.cfm?fuseaction=Search.ShowAdvancedSearchForm Clinical Investigator Inspection List File for Download (NB large file sizes; while not as enormous as BMIS files, CLIIL data files should be imported into a database program like Microsoft Access® or FileMaker Pro®): http://www.fda.gov/Drugs/InformationOnDrugs/ucm135198.htm Clinical Investigator Inspection List Database Code Definitions (what the Classification and Deficiency codes mean): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/ucm073059.htm FDA Center for Biologic Evaluation and Research (CBER) Clinical Investigator Inspection List – Find information about FDA inspections of Clinical Investigators conducting studies with biologics (vaccines, antibodies, etc.): FDA Center for Biologic Research and Evaluation Clinical Investigator Inspection List: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/ucm195364.htm FDA Good Clinical Practice Contacts : http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090343.htm FDA Office of Scientific Investigations (fka DSI) Main Page: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090085.htm FDA Division of Scientific Investigations (DSI) Index of Enforcement Actions: http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090279.htm FDA Compliance Activities Index: http://www.fda.gov/cdrh/comp/index.html top
The following sections of FDA's Compliance Program Manual provide instruction to agency personnel inspecting clinical investigators and institutional review boards:
Food and Drug Administration Compliance Program Guidance Manual (7348.809). Chapter 48. Bioresearch Monitoring – Drugs, Devices, Biologics, and Food; Institutional Review Boards. 1994-10-01 (Implementation date) Accessed on 2010-08-13: http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133768.pdf Food and Drug Administration Compliance Program Guidance Manual (7348.811). Chapter 48. Bioresearch Monitoring; Clinical Investigators. Accessed on 2010-08-13: http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133562.htm CPGM Index: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm160670.htm
FDA Warning Letters and Administrative Actions
FDA Warning Letters (1996-): http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm FDA Recently Posted Warning Letters: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#Recent
FDA Center for Drug Evaluation and Research (CDER) Warning Letters and Notice of Violation Letters to Pharmaceutical Companies (Warning Letters from Bioresearch Monitoring inspections and Notice of Violation Letters to Pharmaceutical Companies for drug advertising, 1998-2009): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/default.htm FDA Center for Biologic Evaluation and Research (CBER) Enforcement Actions: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/default.htm FDA Cyber Letters (Dietary Supplement Warning Letters): http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/CyberLetters/default.htm Clinical Investigators - Disqualification Database (Notice of Initiation of Disqualification Proceedings and Opportunity to Explain [NIDPOE] and Notice of Opportunity for Hearing [NOOH] Letters): http://www.accessdata.fda.gov/scripts/SDA/sdNavigation.cfm?sd=clinicalinvestigatorsdisqualificationproceedings&previewMode=true&displayAll=true FDA Disqualified/Restricted/Assurances Lists For Clinical Investigators (administrative actions against researchers who commit serious violations): http://www.fda.gov/ICECI/EnforcementActions/DisqualifiedRestrictedAssuranceList/default.htm FDA Debarment List: http://www.fda.gov/ICECI/EnforcementActions/FDADebarmentList/default.htm Public Health Services Administrative Actions Listing (administrative sanctions against investigators for violations in research supported by federal grants): http://silk.nih.gov/public/cbz1bje.@www.orilist.html FDA Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/ucm143242.htm Application Integrity Policy List (entities accused of fraud in marketing applications): http://www.fda.gov/ICECI/EnforcementActions/ApplicationIntegrityPolicy/ucm134453.htm FDA Office of Regulatory Affairs (ORA) Frequently Requested Documents (Form FDA 483s and Establishment Inspection Reports from recent high-profile cases): http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm FDA FOIA Electronic Reading Rooms
FDA Electronic Reading Rooms Main Index: http://www.fda.gov/RegulatoryInformation/FOI/ElectronicReadingRoom/default.htm FDA Center for Drug Evaluation and Research (CDER) Electronic Reading Room: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm113237.htm FDA Biologics (CBER) Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm129132.htm FDA Center for Devices and Radiological Health (CDRH) FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHFOIAElectronicReadingRoom/default.htm FDA Office of Regulatory Affairs (ORA) FOIA Electronic Reading Room: http://www.fda.gov/AboutFDA/CentersOffices/ORA/ORAElectronicReadingRoom/default.htm FDA Warning Letters and Administrative Actions Organized on the CIRCARE Web Site
FDA Warning Letters to Clinical Investigators A Through E FDA Warning Letters to Clinical Investigators F Through L
FDA Warning Letters to Clinical Investigators M Through R
FDA Warning Letters to Clinical Investigators S Through Z
FDA Warning Letters to Institutional Review Boards (IRBs) Forms FDA 483 Notices of Inspectional Findings. (A small selection of 483s from CIRCARE's collection.) top
FDA Guidance Documents and Information
2011-06-27: we're working on updating FDA guidance and information. Please be aware some of the links below may be outdated. We apologize for any inconvenience. The FDA Information Sheet Guidances for Institutional Review Boards and Clinical Investigators, aka Information Sheets, are reasonably accessible to non-professionals and provide an accurate overview of FDA regulation of research:
The Information Sheets are one of the best places to find out what investigators, sponsors, and IRBs are supposed to do. FDA Information Sheet Guidances, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Index): http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm113709.htm FDA Information Sheet Guidances, Guidance for Institutional Review Boards and Clinical Investigators, Frequently Asked Questions. 2010-10-18: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm In January 2006 FDA began revising the Information Sheets and reissuing them as guidances. Below are the first five revised Information Sheet guidances. FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: FDA Inspection of Clinical Investigators. 2006-01: http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0001.pdf FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections. 2006-01: http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0002.pdf FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Waiver of IRB Requirements for Drug and Biological Products Studies. 2006-01: http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0003.pdf FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Significant Risk and Nonsignificant Risk Medical Device Studies. 2006-01: http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0004.pdf FDA Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Frequently Asked Questions About Medical Devices. 2006-01: http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0005.pdf FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects 2009-10: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM187772.pdf
FDA Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials. 2006-03: http://www.fda.gov/RegulatoryInformation/Guidances/ucm127004.htm [2011-06-27: Removed for revision] FDA Guidance for Industry: Guideline for the Monitoring of Clinical Investigations. 1998-01 See the Index of Selected FDA/GCP Clinical Trial Guidance Documents at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInformationSheetsandNotices/ucm219433.htm FDA Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. 2002-03: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126838.pdf FDA Guidance: Financial Disclosure by Clinical Investigators. 2001-03-20: http://www.fda.gov/RegulatoryInformation/Guidances/ucm126832.htm Draft Guidance: Financial Disclosure by Clinical Investigators 2011-05: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM256525.pdf
FDA Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. 2004-05-12: http://www.hhs.gov/ohrp/policy/fguid.pdf FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. 2006-01: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf Replies to Inquiries to FDA on Good Clinical Practice FDA Good Clinical Practice Contacts Running Clinical Trials (Index of guidance and information resources.) FDA Regulations Relating to Good Clinical Practice and Clinical Trials Proposed Regulations and Draft Guidances on Good Clinical Practices and Clinical Trials Reporting Suspension or Termination of IRB Approval Clinical Trials Guidance Documents Comprehensive Index of FDA Guidance Documents for Regulated Industry National Library of Medicine Clinicaltrials.gov Fact Sheet top
21 CFR 50 Protection of Human Subjects: Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug Administration, Department of Health and Human Services Part 50. Protection of Human Subjects (Informed Consent): http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=50&showFR=1 21 CFR 54 Financial Disclosure by Clinical Investigators: Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug Administration, Department of Health and Human Services Part 54. Financial Disclosure by Clinical Investigators: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=54&showFR=1 21 CFR 56 Institutional Review Boards: Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug Administration, Department of Health and Human Services Part 56. Institutional Review Boards: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=56&showFR=1 21 CFR 312 Investigational New Drug Applications: Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug Administration, Department of Health and Human Services Part 312. Investigational New Drug Applications: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=312&showFR=1 21 CFR 812 Investigational Device Exemptions: Code of Federal Regulations, Title 21 Food and Drugs, Food and Drug Administration, Department of Health and Human Services Part 812. Investigational Device Exemptions: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=812&showFR=1 Preambles to Good Clinical Practice Regulations: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm#Preambles 21 USC 321 Drug: United States Code, Title 21 Food and Drugs, Chapter 9 Federal Food, Drug, and Cosmetic Act, Subchapter 11. Definitions. Available from http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:21USC321.pdf Comparison Chart of FDA vs. DHHS Regulations. (Chart formatted for printing in HTML or PDF, courtesy of CIRCARE.) Available from http://www.circare.org/FDA_v_HHS.htm GPOAccess Federal Register Database Search: http://www.gpoaccess.gov/fr/index.html Code of Federal Regulations Title 21 Database Search: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm GPOAccess United States Code Database search: http://www.gpoaccess.gov/uscode/index.html GPOAccess United States Code Title 21 Food and Drugs, Chapter 9, Federal Food, Drug, and Cosmetic Act: http://tinyurl.com/y3hwc7n top
Awaiting revision 2010-04-18. FDA publishes proposed rules, regulations, and guidances in its dockets. Public comments are often solicited. Each entry gives a link to the proposed rule or guidance followed by the link to the docket where public comments received to date are posted. Usually FDA creates an index page with the notice and text of the proposed rule, regulation, or guidance, hearing transcripts (if applicable), and public comments. Docket No. 2007D-0106. Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting — Improving Human Subject Protection; Availability. Pages 17562-17563 [FR Doc. E7-06595] Comments due by 2007-06-08 Notice of Availability (text file): http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6595.htm Notice of Availability (pdf file): http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6595.pdf Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting — Improving Human Subject Protection: http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf Docket No. 2006D-0331, OC 2006160. Conduct of Emergency Clinical Research; Public Hearing. Hearing Held October 16, 2006. 2006-08-08. (PrePUB) Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-nhc0001.pdf 2006D-0331 — FDA Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Exception From Informed Consent Requirement in Emergency Research Draft Guidance. July 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0331-gdl0001.pdf Docket No. 2006D-0347, CDRH 200641 Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays. 2006-09-07. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0347-gdl0001.pdf. Comments due by 2006-12-06. Docket No. 2006D-0172, OC 200690 Draft Guidance for Clinical Investigators, Institutional Review Boards, and Sponsors; Process for Handling Pediatric Referrals to the Food and Drug Administration: Additional Safeguards for Children in Clinical Investigations. Pages 27264-27266 [FR Doc. E6-07058 ] Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0172-gdl0001.pdf Docket No. 2006D-0017, OC 2005334 Human Subject Protection Information for Institutional Review Boards, Clinical Investigators, and Sponsors; Rescission, Reissuance, and Development of Food and Drug Administration Guidance Documents; Availability. Pages 5861-5862 [FR Doc. E6-1476]. 2006-02-03. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-1476.pdf The Guidance Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors, FDA Inspections of Clinical Investigators. January, 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0017-gdl0001.pdf The Guidance Information Sheet Guidance For Sponsors, Clinical Investigators, and IRBs: Waiver of IRB Requirements for Drug and Biological Product Studies. January, 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0017-gdl0003.pdf The Guidance Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies. January, 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0017-gdl0004.pdf The Guidance Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Frequently Asked Questions About Medical Devices. January, 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0017-gdl0005.pdf The Guidance Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors: FDA Institutional Review Board Inspections. January, 2006. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/06d-0017-gdl0002.pdf Docket No. 2005N-0507 Agency Emergency Processing Under Office of Management and Budget Review; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable. 2006-01-09. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-73.htm Docket No. 2005N-0507 Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable. 2006-03-28. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0507-nal0001.pdf Docket No. 2005N-0507 Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable. Supporting Statement. 2006-03-28. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0507-ss00001.pdf Docket No. 2003N-0273 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Research Study Complaint Form. 2005-12-08. Available from http://www.fda.gov/ohrms/dockets/98fr/05-24102.htm Docket No. 2001N-0322 Institutional Review Boards: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Board Reviews; Withdrawal. 2006-01-17. Available from http://a257.g.akamaitech.net/7/257/2422/01jan20061800/edocket.access.gpo.gov/2006/E6-357.htm Selected public comment submitted to FDA Docket 2001N-0322:
Wood JJ. Assistant Vice Chancellor for Research Vanderbilt University Medical Center. Docket 2001N-0322: Institutional Review Boards. Comment Number: EC-13. 2002-06-04. Available from http://www.fda.gov/ohrms/dockets/dailys/02/Jun02/060702/01N-0322-EC-13.html Comment: It's peculiar that Vanderbilt claims to be unaware of any instances of IRB shopping. During his interview with FDA Dr. Steven Heymsfield asserted the disastrous 6 month study of Metabolife 365® was placed with Carol Boozer at Roosevelt-St Luke's Hospital after sponsor Metabolife Inc. refused the Vanderbilt IRB's demand to file an IND application (p. 4): Laska SF, Love LA. FDA Office of Regulatory Affairs Memorandum of Interview with Steven B. Heymsfield M.D. 2002-10-18. Available from http://energycommerce.house.gov/108/Hearings/07232003hearing1021/104.pdf Docket No. 2005D-0122 Guidance for Industry on Exploratory IND Studies. 2005-04-13. Available from http://www.fda.gov/ohrms/dockets/dockets/05d0122/05d0122.htm. (Index to FDA Docket 2005D-0122.) Docket No. 2005D-0103 Draft Guidance for Industry Using Centralized IRB Review Process in Multicenter Clinical Trials. 2005-03-25. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/05d-0103-gdl0001.pdf Docket No. 2005D-0103 Guidance for Industry Using Centralized IRB Review Process in Multicenter Clinical Trials. 2005-03-25. Index to FDA Docket 2005D-0103. Available from http://www.fda.gov/ohrms/dockets/dockets/05d0103/05d0103.htm Docket No. 2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing, Background Information. 2005-02-07. Available from http://www.fda.gov/OHRMS/DOCKETS/98fr/oc04297.pdf Docket No. 2005N-0038 Reporting of Adverse Events to Institutional Review Boards; Public Hearing. 2005-02-07. Index to FDA Docket 2005N-0038. Available from http://www.fda.gov/ohrms/dockets/dockets/05n0038/05n0038.htm Related: NIH Regulatory Burden V. Human Subjects Protection Workgroups Report. 1999-03-10. Available from http://grants2.nih.gov/grants/policy/regulatoryburden/humansubjectsprotection.htm. (Background and context.) Docket No. 2004N-0242 Proposed Rule: Institutional Review Boards; Registration Requirements. 2004-07-06. Available from http://www.fda.gov/ohrms/dockets/98fr/04-15131.htm top
How to Comment on Proposed FDA Regulations and Submit Petitions Submit Comments to FDA Dockets FDA Dockets Comments Frequently Asked Questions FDA Dockets Currently Open for Comment Comprehensive FDA Docket List FDA Dockets Home FDA Information Resources and Publications
FDA News Release Index (1987- ): http://web.archive.org/web/20071010132357/http://www.fda.gov/opacom/hpnews.html (Includes press releases and FDA Talk Papers from 1992 onwards.) FDA Press Announcements (2004- ): http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm FDA Congressional Testimony and Archive (1996-): http://www.fda.gov/NewsEvents/Testimony/default.htm FDA Consumer, the official publication of the U.S. Food and Drug Administration, is a good source of (historical) FDA information: FDA Consumer Published online from 1989-2007: http://web.archive.org/web/20070716182210/http://www.fda.gov/fdac/fdacindex.html Alternate source: FDA Consumer at Findarticles.com (Current Issues and Archives 1984 -): http://findarticles.com/p/articles/mi_m1370/ FDA Consumer Magazine devoted a full issue to a special report titled From Test to Patient Protecting America's Health Through Human Drugs. The report was updated in 2006. With all due respect to FDA, readers should be aware that FDA doesn't have the resources to inspect study sites and institutional review boards. The overwhelming majority of inspections are done long after studies are finished, during routine data audits prior to approval of new drug applications (NDAs), generic drug applications (ANDAs), and medical device Premarket Approval Applications (PMAs). With this cautionary note:
From Test to Patient Protecting America's Health Through Human Drugs. A Special Report From the FDA Consumer Magazine and the FDA Center for Drug Evaluation and Research. Fourth Edition. January, 2006: http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143455.htm (FDA reports on trial registration at Clinicaltrials.gov): FDAMA Section 113: Status Report on Implementation. 2005-08: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm143810.htm FDAMA Section 113: Analysis of Cancer Trials Submitted May - July, 2005. 2006-06: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ParticipatinginClinicalTrials/ucm148942.htm FDA Public Calendar (1998-2008): http://web.archive.org/web/20080223123114/http://www.fda.gov/opacom/calendar.html (The FDA Public Calendar lists meetings held by FDA policy makers with persons outside the executive branch of the Federal government.) Past Meetings with FDA Officials (2007- ): http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/default.htm FDA Homepage FDA History
FDA History Main Page: http://www.fda.gov/AboutFDA/WhatWeDo/History/default.htm Bren L. Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer. March / April 2001: http://web.archive.org/web/20080407094614/http://www.fda.gov/fdac/features/2001/201_kelsey.html Lisook AB. The History of FDA's Bioresearch Monitoring Program. 15th Annual Meeting of Associates of Clinical Pharmacology. San Diego, CA. 1991-04-29: http://web.archive.org/web/20051115031019/http://www.fda.gov/cder/Offices/DSI/Lisook.pdf Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident. FDA Consumer. June 1981: http://web.archive.org/web/20080223153844/http://www.fda.gov/oc/history/elixir.html The Long Struggle For The 1906 Law. FDA Consumer. June 1981: http://web.archive.org/web/20080223170721/http://www.cfsan.fda.gov/~lrd/history2.html The Story of the Laws Behind the Labels / Part I 1906 Food and Drugs Act. FDA Consumer. June 1981: http://web.archive.org/web/20080223143206/http://vm.cfsan.fda.gov/~lrd/history1.html The Story of the Laws Behind the Labels / Part II: 1938 Federal Food, Drug, and Cosmetic Act. FDA Consumer. June 1981: http://web.archive.org/web/20080223231935/www.cfsan.fda.gov/~lrd/histor1a.html The Story of the Laws Behind the Labels / Part III: 1962 Drug Amendments. FDA Consumer. June 1981: http://web.archive.org/web/20080223184357/www.cfsan.fda.gov/~lrd/histor1b.html Hamilton D. A Brief History of the Center for Drug Evaluation and Research. FDA History Office. November, 1997. Available from http://web.archive.org/web/20080210151538/http://www.fda.gov/cder/about/history/Histext.htm Swann JP. FDA's Origins. Adapted from: George Kurian, ed., The Historical Guide to American Government (New York: Oxford University Press, 1998: http://www.fda.gov/AboutFDA/WhatWeDo/History/Origin/ucm124403.htm Index of FDA History Publications: http://web.archive.org/web/20080221194800/http://www.fda.gov/oc/history/historypubs.html FDA Oral Histories (highly recommended): http://www.fda.gov/AboutFDA/WhatWeDo/History/OralHistories/default.htm Research Tools on FDA History: http://www.fda.gov/AboutFDA/WhatWeDo/History/ResearchTools/default.htm Selected Sources on the History of FDA (Bibliograpy, current to 2008-02): http://web.archive.org/web/20080223194911/http://www.fda.gov/opacom/morechoices/sources.html FDA Advisory Committee Information
FDA Advisory Committees Main Index. Available from http://www.fda.gov/ohrms/dockets/ac/acmenu.htm FDA Center for Devices and Radiological Health (CDRH) Advisory Committees Database Search. Available from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfAdvisory/search.cfm FDA Advisory Committees Nature and Basis Statements of Conflict(s) of Interest for Voting Members of FDA Advisory Committee Members (2006). Available from http://www.fda.gov/ohrms/dockets/ac/currentcoi.html FDA Advisory Committees Nature and Basis Statements of Conflict(s) of Interest for Voting Members of FDA Advisory Committee Members (2005). Available from http://www.fda.gov/ohrms/dockets/ac/2005coi.html FDA Enforcement: Office of Criminal Investigations (OCI)
FDA Office of Criminal Investigations: http://www.fda.gov/ICECI/CriminalInvestigations/default.htm FDA Office of Criminal Investigations Field Office Contact Information 2011-06-27: http://www.fda.gov/ICECI/CriminalInvestigations/ucm123034.htm
FDA Office of Regulatory Affairs Directory (OCI staff) 2009-04-19: http://web.archive.org/web/20090419063130/http://www.fda.gov/ora/inspect_ref/iom/pdf/directory.pdf The annual FDA Enforcement Story describes criminal cases handled by OCI, updates court cases, and summarizes warning letters by center. Consult the table of contents for OCI activities. Enforcement Story Archive 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/default.htm Enforcement Story 2008 (2009-03) 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/default.htm
Enforcement Story 2007 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm155828.htm
Enforcement Story 2006 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090818.htm Enforcement Story 2005 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090823.htm Enforcement Story 2004 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090825.htm Enforcement Story 2003 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090827.htm Enforcement Story 2002 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090828.htm Enforcement Story 2001 (Updated 2003-08-07) 2011-06-27: http://www.fda.gov/ICECI/EnforcementActions/EnforcementStory/EnforcementStoryArchive/ucm090830.htm FDA Office of Regulatory Affairs Headquarters Directory 2011-06-27: http://www.fda.gov/ICECI/Inspections/IOM/ucm124051.htm FDA Errata
FDA Investigations Operations Manual. Ch. 8, Investigations. (FDA inspection, in detail) 2011-06-27: http://www.fda.gov/ICECI/Inspections/IOM/ucm123471.htm FDA at its Finest:
'Heroine' of FDA Keeps Bad Drug Off Market Morton Mintz Washington Post 1962-07-15: http://www.washingtonpost.com/wp-srv/washtech/longterm/thalidomide/keystories/071598drug.htm FDA Center for Drug Evaluation and Research Special Interest Topics 2011-06-27: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/ucm113237.htm. (Personal suggestions: Robert Temple M.D. to IOM on FDA Advisory Committees; Seminar Transcript titled The Use of Placebos in Clinical Trials and the Ethics of the Use of Placebos.) If you've ever wondered what happens when FDA objects to proposed research under an IND application, e.g., when a clinical hold is imposed, here's an example: Woodcock J. Letter to Robert Friedland M.D., re: IND 5059 / Technetium-Tc-99m Conjugated Murine Monoclonal Antibody (10H3) to Beta Amyloid Protein. 1993-06-17. Available from http://www.circare.org/foia5/ind5059clinicalholdandreply.pdf FDA Mission: The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
FDA: A Shell of its Former Self. M. Asif Ismail. The Center for Public Integrity. 2005-07-07: http://projects.publicintegrity.org/rx//report.aspx?aid=722 Hard To Find Information: The FDA requirement that an IRB reviewing investigational new drugs studies include a licensed physician is at 46 FR 8942 at 8966, 1981-01-27. The requirement that an IRB reviewing investigational new device studies include a licensed physician is in the Medical Device Amendments of 1976. Best way to locate Center for Drug Evaluation and Research (CDER) information: http://www.fda.gov/Drugs/NewsEvents/default.htm This is what a New Drug Application (e.g., a marketing application) looks like – this is a small one: top
If you find the information on this page helpful please support CIRCARE with a tax-deductible contribution today. Because CIRCARE doesn't accept funds from pharmaceutical or medical device manufacturers, we depend on contributions from individuals like you to help us advocate for meaningful protection of human subjects in research. Donating online with PayPal is quick and easy. Find out more on our Support page All material on this site © CIRCARE Incorporated (2002– ) or as indicated. Single copies can be downloaded for personal education. Adobe® Reader :: ::