FDA Debarment List - Firms or persons convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any new or abbreviated drug application.
Clinical Investigators - Disqualification Proceedings
Public Health Service Administrative Actions Listing (Link to external document, not maintained by FDA/ORA)
Compliance Policy Guides - Bimo Related:International Memoranda of Understanding (June, 1995) Link to FDA International Program WebSiteFraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities (CPG 7150.09) (July, 1991)FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02) (January 1996)
Guidance for Industry:Good Laboratory Practice Regulations Management Briefings Post Conference ReportAugust 1979 (HTML)n/aComputerized Systems Used in Clinical InvestigationsMay 2007August 2011The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and ResearchersAugust 2010
FDA Regulations - Title 21 Code of Federal Regulations:Part 50--PROTECTION OF HUMAN SUBJECTSPart 56--INSTITUTIONAL REVIEW BOARDSPart 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESPart 312--INVESTIGATIONAL NEW DRUG APPLICATIONPart 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTSPart 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USEPart 812--INVESTIGATIONAL DEVICE EXEMPTIONS
- Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD)Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976HTML N/AHTML N/A
OECD GLP Internet (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)