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  3. Compliance Actions and Activities
  4. FDA Bioresearch Monitoring Information
  1. Compliance Actions and Activities

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 PDF
Guidance: Exception from Informed Consent-Emergency Research August 2011 PDF
The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and Researchers August 2010 PDF

FDA Regulations

TITLE 21 CODE OF FEDERAL REGULATIONS

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 PDF
Good Laboratory Practice (GLP) Final Rule, 12/22/1978 PDF
Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984 PDF
Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987 PDF
OECD GLP InternetExternal Link Disclaimer (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)  

 



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