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FDA Research Regulations and Information

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

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?

What information is available elsewhere on the CIRCARE web site?

FDA Division of Scientific Investigations

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.):

FDA Good Clinical Practice Contacts : http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm090343.htm

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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 FOIA Electronic Reading Rooms

FDA Warning Letters and Administrative Actions Organized on the CIRCARE Web Site

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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

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FDA Regulations

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FDA Dockets

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

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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:

boxes of documents for fda new drug application


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