Food & Drug Administration

Under construction 2004-10-19. Your patience is appreciated.

Alphabet Soup (US 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 HHS); HHS: Health and Human Services; OHRP: Office For Human Research Protections (part of HHS); ORI: Office of Research Integrity (part of HHS); OIG: Office of the Inspector General

History

Milestones in U.S. Food and Drug Law History

FDA Regulations – Code of Federal Regulations

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
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
Code of Federal Regulations, Title 21: Food and Drugs, Food and Drug Administration, Department of Health and Human Services; Part 56: Institutional Review Boards
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
Code of Federal Regulations, Title 21: Food and Drugs, Food and Drug Administration, Department of Health and Human Services; Part 812: Investigational Device Exemptions

FDA Regulation – Compliance

FDA Regulations Relating to Good Clinical Practice and Clinical Trials
Preambles to GCP Regulations
Pediatric Research Equity Act of 2003
FDA Division of Scientific Investigations
FDA Guidance for Institutional Review Boards and Clinical Investigators (the Information Sheets for clinical investigators)
Good Clinical Practice in FDA-Regulated Clinical Trials (Index)
Suspension or Termination of IRB Approval, Good Clinical Practice in FDA-Regulated Clinical Trials
FDA/CDER Information Program on Clinical Trials for Serious or Life-Threatening Diseases and Conditions
Agency guidance for submitting trials to ClinicalTrials.gov
FDA Compliance Activities (extensive well-organized collection of current reference material, Compliance Guidances, and agency actions, especially for medical devices)

Complain About FDA-Regulated Products

MedWatch FDA Safety Information and Adverse Event Reporting Program (MedWatch Online Reporting Form - Report adverse events with FDA-regulated products)
Report Suspected Illegal Drug Sales Online
FDA Health Fraud Directory (definitions, local contacts)

Information & Complaints About Clinical Research With FDA-Regulated Products

Reporting Complaints and Finding Information Related to FDA-Regulated Clinical Trials [studies conducted under an IND, IDE, drugs, medical devices, cosmetics, and dietary supplements

Medical Devices

Medical Device Acronyms (unscrambled courtesy of the Food and Drug Law Institute)
Primer on Medical Device Regulation Monsein, L. Radiology 1997; 205:1 - 9
FDA CDRH Advisory Committee Database
FDA CDRH Advisory Committee Transcripts (older material)
510(K) Database Search (Find out if a device is approved for marketing on the basis of Substantial Equivalence (SE) and for what indication(s))
Humanitarian Use Devices (list of designated devices and summaries of safety and possible benefit)
Devices@FDA
Humanitarian Device Exemptions (HDE) Regulation - Questions and Answers, Final Guidance for Industry
IDE Policies and Procedures (comprehensive information on Investigational Device Exemption submission)
Device Listing Database Search (Find foreign and domestic devices in commercial distribution)
OIVD Office of In Vitro Diagnostic Device Evaluation and Safety
Medical Device Adverse Event Reporting Data Files (searchable databases for adverse events with devices)
MAUDE Database (searchable database for adverse events with devices)
CDRH User Facility Reporting Bulletins
FDA Center For Devices and Radiological Health, Consumer Resources (excellent straightforward introduction to the regulation of medical devices)

FDA Dockets

How to Comment on Proposed Regulations and Submit Petitions
Dockets Comments Frequently Asked Questions
All FDA Dockets Currently Open for Comment
Comprehensive Docket List (with links to documents)
FDA Dockets Home

Miscellaneous

Index of FDA Databases
Code of Federal Regulations, Title 21 Database Search
FDA News Releases [archive of FDA press releases and talk papers: 1987- ]
Search the FDA Web site

Holding (temporary

to be relocated in FOIA

FDA Division of Scientific Investigations, Investigational Human Drugs Clinical Investigator Inspection List (links to variously disqualified clinical investigators and ASCII file (very large) containing data from FDA inspections of clinical investigators)
FDA Division of Scientific Investigations, Index of Enforcement Actions
FDA Division of Scientic Investigations, Bioresearch Monitoring Information System File (careful: large ASCII file)
FDA Disqualified/Restricted/Assurances Lists For Clinical Investigators (Administrative actions against researchers who commit serious violations)
Public Health Services Administrative Actions Listing (Administrative sanctions against investigators for violations during the conduct of research supported by federal grants)
FDA Presiding Officer Reports and Commissioner's Decisions in Clinical Investigator Disqualifications Proceedings (Review/appeal of administrative actions to disqualify or debar clinical investigators - provides excellent insight on how the current regulatory system works, and doesn't work)
FDA Electronic Reading Room – Warning Letters
FDA Warning Letters Indexed by Company (1999- ) (Courtesy of Pharmcast.com)
FDA Warning Letters - synopsized (Courtesty of FDAwebview)
FDA Center for Drug Evaluation and Research, Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
FDA CBER Warning Letters (Vaccines and Biologics)
FDA Cyber Letters (Dietary Supplements)
FDA Notice of Initiation of Disqualification Proceedings and Opportunity to Explain Letters (NIDPOE)
FDA Notice of Opportunity for Hearing Letters (NOOH)
FDA Office of Regulatory Affairs, Frequently Requested Documents and FDA Form 483s
FDA Index of Categories of Documents Electronic Reading Room (Index of material released and available online through the Freedom of Information Act)

Warning Letters — CDER (drugs)

Warning Letters — Cyber Letters (Dietary Supplements)

FDA Press Release, explaining Cyber Letters [2000-02-02]
2004 Index
2003 Index
2002 Index
2001 Index
2000 Index

Archived Warning Letters Index (November 1996 to October 2003) – Subjects (translation: all warning letters released thru FOIA alphabetized by subject)
Archived Warning Letters Index (October 2003 — October 2004

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Last Updated: 2004-11-05