Inspections, Compliance, Enforcement, and Criminal Investigations

Bioresearch Monitoring

Compliance Lists:

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.

Disqualified/Restricted/Assurance List for Clinical Investigators

Nonclinical Laboratories Inspected under GLP Regulations since FY 1990

Public Health Service Administrative Actions Listing (Link to external document, not maintained by FDA/ORA)

100.900	International Memoranda of Understanding (June, 1995) Link to FDA International Program WebSite
120.100	Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities (CPG 7150.09) (July, 1991)
130.300	FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02) (January 1996)

Good Laboratory Practice Regulations Management Briefings Post Conference Report	August 1979 (HTML)	n/a
GLP Questions and Answers	HTML	PDF, 52 KB
Computerized Systems Used In Clinical Trials	April 1999 (HTML)	PDF, 46 KB
Guidance: Exception from Informed Consent-Emergency Research	August 2011	PDF, 300 KB
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and Researchers	August 2010	PDF, 276 KB

Part 50--PROTECTION OF HUMAN SUBJECTS	HTML
Part 56--INSTITUTIONAL REVIEW BOARDS	HTML
Part 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES	HTML
Part 312--INVESTIGATIONAL NEW DRUG APPLICATION	HTML
Part 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS	HTML
Part 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE	HTML
Part 812--INVESTIGATIONAL DEVICE EXEMPTIONS	HTML

Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD)	HTML	PDF, 1.8 MB
Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976	HTML N/A	PDF, 6.2 MB
Good Laboratory Practice (GLP) Final Rule, 12/22/1978	HTML N/A	PDF, 8.4 MB
Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984	HTML	PDF, 1.8 MB
Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987	HTML	PDF, 3.2 MB
OECD GLP Internet (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)