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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Bioresearch Monitoring

 FDA/ORA Bioresearch Monitoring Information Page
 


Background
 
 
 

  • Compliance Policy Guides - Bimo Related:

    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) (January 1996)
 
 

  • Guidance for Industry:

    Good Laboratory Practice Regulations Management Briefings Post Conference Report August 1979 (HTML) n/a
    GLP Questions and Answers  HTML PDF, 52 KB
    Computerized Systems Used In Clinical Trials April 1999 (HTML) PDF, 46 KB
    Guidance: Exception from Informed Consent-Emergency Research  August 2011 PDF, 300 KB
    The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and Researchers August 2010 PDF, 276 KB
 

  • FDA Regulations - Title 21 Code of Federal Regulations:

    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
 

  •  Good Laboratory Practice (GLP) Resources:


    Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD) HTML PDF, 1.8 MB
    Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976 HTML N/A PDF, 6.2 MB
     Good Laboratory Practice (GLP) Final Rule, 12/22/1978 HTML N/A PDF, 8.4 MB
    Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984 HTML PDF, 1.8 MB
    Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987 HTML PDF, 3.2 MB
    OECD GLP Internet (Organization for Economic
    Co-operation and Development) (Link to an external site, not part of the FDA web)

 

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