FDA Bioresearch Monitoring Information
FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, as well as, to provide for protection of the rights and welfare of the thousands of human subjects and animals involved in FDA regulated research. Read More
Application Integrity
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. - Clinical Investigators - Disqualification Proceedings
- Public Health Service Administrative Actions Listing
The PHS Administrative Action Bulletin Board includes the names of individuals who currently have administrative actions imposed against them by the Office of Research Integrity (ORI), the Assistant Secretary of Health and/or the Department of Health and Human Services (HHS). (External site/not maintained by FDA/ORA)
Compliance Policy Guides - BIMO Related
| Guide # | Title | Date |
|---|---|---|
| 100.900 | International Memoranda of Understanding *Also see: FDA's International Programs | June, 1995 |
| 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) | June, 2007 |
Compliance Programs
Guidance for Industry
| Guidance Title | Date | Online Availability |
|---|---|---|
| Good Laboratory Practice Regulations Management Briefings Post Conference Report | August 1979 | HTML |
| GLP Questions and Answers | n/a | HTML / PDF |
| Computerized Systems Used in Clinical Investigations | May 2007 | |
| Guidance: Exception from Informed Consent-Emergency Research | August 2011 | |
| The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and Researchers | August 2010 | |
| Processes and Practices Applicable to Bioresearch Monitoring Inspections | December 2025 |
FDA Regulations
TITLE 21 CODE OF FEDERAL REGULATIONS
- PART 50—Protection of Human Subjects
- PART 56—Institutional Review Boards
- PART 58—Good Laboratory Practice for Nonclinical Laboratory Studies
- PART 312—Investigational New Drug Application
- PART 320—Bioavailability and Bioequivalence Requirements
- PART 511—New Animal Drugs for Investigational Use
- PART 812—Investigational Device Exemptions
Good Laboratory Practice (GLP) Resources
| Resource Title | Online Availability |
|---|---|
| Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD) | HTML / PDF |
| Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976 | |
| Good Laboratory Practice (GLP) Final Rule, 12/22/1978 | |
| Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984 | |
| Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987 | |
| OECD GLP InternetExternal Link Disclaimer (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web) |