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) (Jan. 1996)

In Vivo Bioequivalence	7348.001 (HTML)	78 KB
Good Laboratory Practice (Non-Clinical Laboratories)	7348.808 (HTML)	3.3 MB
Good Laboratory Practice (EPA Data Audit Inspections)	7348.808A (HTML)	31 KB
Institutional Review Boards (IRB)	7348.809 (HTML Not Available (N/A))	1.05 MB
Sponsors, Contract Research Organizations and Monitors	7348.810 (HTML)	1.8 MB
Clinical Investigators (CI)	7348.811 (HTML)	3.24 MB

Good Laboratory Practice Regulations Management Briefings Post Conference Report	Aug. 1979 (HTML)	n/a
GLP Questions and Answers	HTML	52 KB
Computerized Systems Used In Clinical Trials	Apr. 1999 (HTML)	46 KB
Guideline for the Monitoring of Clinical Investigations	Jan. 1988 (HTML)	PDF,16kb
Draft Guidance: Exception from Informed Consent-Emergency Research	July 2006	2.86 MB

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	1.79 mb
Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976	HTML N/A	6170 KB
Good Laboratory Practice (GLP) Final Rule, 12/22/1978	HTML N/A	8355 KB
Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984	HTML	1762 KB
Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987	HTML	3167 KB
OECD GLP Internet (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)