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        Compliance Actions and Activities

FDA Bioresearch Monitoring Information

                        
                Bioresearch Monitoring Program Information Home
          Inspections, Compliance, Enforcement, and Criminal Investigations
          Compliance Actions and Activities
          FDA Bioresearch Monitoring InformationCompliance Actions and Activities FDA Bioresearch Monitoring Information
  	
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    PrintFDA'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

Application Integrity PolicyCompliance 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
			Date100.900
			International Memoranda of Understanding
			*Also see: FDA's International Programs
			June, 1995120.100
			Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities (CPG 7150.09)
			July, 1991130.300
			FDA Access to Results of Quality Assurance Program Audits and Inspections (CPG 7151.02)
			June, 2007

Compliance Programs

Compliance Programs - BIMO Related
	View all Compliance ProgramsGuidance for Industry

Guidance Title
			Date
			Online AvailabilityGood Laboratory Practice Regulations Management Briefings Post Conference Report
			August 1979
			HTMLGLP Questions and Answers
			n/a
			HTML / PDFComputerized Systems Used in Clinical Investigations
			May 2007
			PDFGuidance: Exception from Informed Consent-Emergency Research
			August 2011
			PDFThe 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

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 ExemptionsGood Laboratory Practice (GLP) Resources

Resource Title
			Online AvailabilityComparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD)
			HTML / PDFGood Laboratory Practice (GLP), Proposed Rule, 11/19/1976
			PDFGood Laboratory Practice (GLP) Final Rule, 12/22/1978
			PDFGood Laboratory Practice (GLP), Proposed Rule, 10/29/1984
			PDFGood Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987
			PDFOECD GLP InternetExternal Link Disclaimer (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)

                                                                                  Content current as of:
      12/22/2020FDA Bioresearch Monitoring Information                
                          

                        Bioresearch Monitoring Program Information
 
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