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Alphabet Soup (U.S. Federal Agencies): CDER: Center For Drug Evaluation and Research; CBER: Center For Biologics Evaluation and Research; CDRH: Center For Devices and Radiological Health; FDA: Food and Drug Administration (part of DHHS); DHHS: Department of Health and Human Services; OHRP: Office For Human Research Protections (part of DHHS); ORI: Office of Research Integrity (part of DHHS); OIG: Office of the Inspector General
2006-09-19: We appreciate your patience while we update and re-organize this web page.
new 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 Draft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting — Improving Human Subject Protection; Availability.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): (External) http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6595.htm
Notice of Availability (pdf file): (External) http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6595.pdfDraft Guidance for Clinical Investigators, Sponsors, and Investigational Review Boards on Adverse Event Reporting — Improving Human Subject Protection: (External) http://www.fda.gov/OHRMS/DOCKETS/98fr/07d-0106-gdl0001.pdf
What Information is Available on this page?
FDA Information Sheet Guidances, Guidance for Institutional Review Boards and Clinical Investigators, Frequently Asked Questionsis generally accessible to non-professionals.)
What Information is Available Elsewhere on the CIRCARE web site?
FDA Bioresearch Monitoring Information System (BMIS) - Find information about clinical investigators and IRBs in drug studies for IND applications:
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:
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.):
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): (External) http://www.fda.gov/ora/compliance_ref/bimo/7348_809/irb-cp7348-809.pdf
Food and Drug Administration Compliance Program Guidance Manual (7348.811). Chapter 48. Bioresearch Monitoring; Clinical Investigators. 1997-10-07: (External) http://www.fda.gov/ora/compliance_ref/bimo/7348_811/default.html
The following is reasonably accessible to non-professionals and provides an accurate overview of FDA regulation of research:
FDA Information Sheet Guidances, Guidance for Institutional Review Boards and Clinical Investigators, Frequently Asked Questions. 1998. Available from (External) http://www.fda.gov/oc/ohrt/irbs/faqs.html
FDA Information Sheet Guidances, Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (Index). 1998. Available from (External) http://www.fda.gov/oc/ohrt/irbs/default.htm . The Information Sheets are one of the best places to find out what investigators, sponsors, and IRBs are supposed to do. 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. Available from (External) 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. Available from (External) 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. Available from (External) 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. Available from (External) 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. Available from (External) http://www.fda.gov/ohrms/dockets/98fr/06d-0017-gdl0005.pdf
FDA Guidance for Industry: Using a Centralized IRB Review Process in Multicenter Clinical Trials. 2006-03. Available from (External) http://www.fda.gov/cder/guidance/OC2005201fnl.pdf
FDA Guidance for Industry: Guideline for the Monitoring of Clinical Investigators. 1998. Available from (External) http://www.fda.gov/ora/compliance_ref/bimo/clinguid.html
FDA Guidance for Industry: Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions. 2002-03. Available from (External) http://www.fda.gov/cder/guidance/4856fnl.htm
FDA Guidance: Financial Disclosure by Clinical Investigators. 2001-03-20. Available from (External) http://www.fda.gov/oc/guidance/financialdis.html
FDA Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. 2004-05-12. Available from (External) http://www.hhs.gov/ohrp/humansubjects/finreltn/finalguid.pdf
FDA Guidance for Industry, Investigators, and Reviewers: Exploratory IND Studies. 2006-01. Available from (External) http://www.fda.gov/cder/guidance/7086fnl.htm
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.
new Docket No. 2006D-0331, OC 2006160. Conduct of Emergency Clinical Research; Public Hearing. Hearing Held October 16, 2006. 2006-08-08. (PrePUB) Available from (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) 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 (External) http://www.fda.gov/ohrms/dockets/98fr/04-15131.htm
FDA News Release Index (1987- ). Available from (External) http://www.fda.gov/opacom/hpnews.html . (Includes press releases and FDA Talk Papers from 1992 onwards.)
FDA Congressional Testimony and Archive (1996-). Available from (External) http://www.fda.gov/ola/listing.html
FDA Consumer, the official publication of the U.S. Food and Drug Administration, is a good source of (historical) FDA information:
FDA Consumer (Current Issues and Archives 1989 -). Available from (External) http://www.fda.gov/fdac/fdacindex.html
Alternate source: FDA Consumer at Findarticles.com (Current Issues and Archives 1984 -). Available from (External) http://www.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. Available from (External) http://www.fda.gov/fdac/special/testtubetopatient/default.htm
(FDA reports on trial registration at Clinicaltrials.gov): FDAMA Section 113: Status Report on Implementation. 2005-08. Available from (External) http://www.fda.gov/oashi/clinicaltrials/section113/113report/default.htm
FDAMA Section 113: Analysis of Cancer Trials Submitted May - July, 2005. 2006-06. Available from (External) http://www.fda.gov/oashi/clinicaltrials/section113/2005statusreport/default.htm
FDA Public Calendar. Available from (External) 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.)
Index of FDA Databases. Available from (External) http://www.fda.gov/search/databases.html
Bren L. Frances Oldham Kelsey: FDA Medical Reviewer Leaves Her Mark on History. FDA Consumer. March / April 2001. Available from (External) 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. Available from (External) http://www.fda.gov/cder/Offices/DSI/Lisook.pdf
Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident. FDA Consumer. June, 1981. Available from (External) http://www.fda.gov/oc/history/elixir.html
The Long Struggle For The 1906 Law. FDA Consumer. June, 1981. Available from (External) 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. Available from (External) 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. Available from (External) http://www.cfsan.fda.gov/~lrd/histor1a.html
The Story of the Laws Behind the Labels / Part III: 1962 Drug Amendments. FDA Consumer. June, 1981. Available from (External) http://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 (External) http://www.fda.gov/cder/about/history/Histext.htm
Swann JP. History of the FDA. in: George Kurian, ed., The Historical Guide to American Government (New York: Oxford University Press, 1998). Available from (External) http://www.fda.gov/oc/history/historyoffda/fulltext.html
Index of FDA History Publications. Available from (External) http://www.fda.gov/oc/history/historypubs.html
FDA Oral History Project. Available from (External) http://www.fda.gov/oc/history/oralhistories/default.htm
A Guide to Resources on the History of the Food and Drug Administration. Available from (External) http://www.fda.gov/oc/history/resourceguide/default.htm
Selected Sources on the History of FDA. Available from (External) http://www.fda.gov/opacom/morechoices/sources.html
FDA Advisory Committees Main Index. Available from (External) http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
FDA Center for Devices and Radiological Health (CDRH) Advisory Committees Database Search. Available from (External) 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 (External) 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 (External) http://www.fda.gov/ohrms/dockets/ac/2005coi.html
FDA Office of Criminal Investigations (OCI) Fiscal Year 2005 (Enforcement Story, Chapter 6). Available from (External) http://www.fda.gov/ora/about/enf_story/ch6/default.pdf
FDA Office of Criminal Investigations (OCI) Fiscal Year 2004 (Enforcement Story, Chapter 6). Available from (External) http://www.fda.gov/ora/about/enf_story2004_archive/ch6/default.pdf
FDA Office of Criminal Investigations (OCI) Fiscal Year 2003 (Enforcement Story, Chapter 6). Available from (External) http://www.fda.gov/ora/about/enf_story/archive/2003/ch6/
FDA Office of Criminal Investigations (OCI) Fiscal Year 2002 (Enforcement Story, Chapter 6). Available from (External) http://www.fda.gov/ora/about/enf_story/archive/2002/ch6/
FDA Office of Criminal Investigations (OCI) Fiscal Year 2001 (Enforcement Story, Chapter 6). Available from (External) http://www.fda.gov/ora/about/enf_story/archive/2001/ch6/ch6_toc.htm
FDA Health Fraud Directory. Available from (External) http://www.fda.gov/ora/fed_state/DFSR_Activities/health_fraud_directory.htm
FDA at its Finest:
FDA Center for Drug Evaluation and Research Special Interest Topics. Available from (External) http://www.fda.gov/cder/foi/special/index.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. Available from (External) http://www.publicintegrity.org/rx/report.aspx?aid=722 . 2005-07-07. Accessed 2006-02-03.
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: (External) What's New at CDER by Date
This is what a New Drug Application (e.g., a marketing application) looks like – this is a small one:
boxes of documents for fda new drug application
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