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  1. Inspections, Compliance, Enforcement, and Criminal Investigations

FDA Bioresearch Monitoring Information

FDA Bioresearch Monitoring Information

FDA/ORA Bioresearch Monitoring Information Page


Background

  • Application Integrity Policy:

  • 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 (Link to external document, not maintained by FDA/ORA)

  • Compliance Policy Guides - Bimo Related:

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

  • Guidance for Industry:

    Good Laboratory Practice Regulations Management Briefings Post Conference Report
    August 1979 (HTML)
    n/a
     
    GLP Questions and Answers
     
    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
  • 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:

    Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD)
     
    Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976
    HTML N/A
     
    Good Laboratory Practice (GLP) Final Rule, 12/22/1978
    HTML N/A
     
    Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984
     
    Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987

    OECD GLP Internet (Organization for Economic Co-operation and Development) (Link to an external site, not part of the FDA web)