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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 ReportAugust 1979 (HTML)n/a
    GLP Questions and Answers HTMLPDF, 52 KB
    Computerized Systems Used In Clinical TrialsApril 1999 (HTML)PDF, 46 KB
    Guidance: Exception from Informed Consent-Emergency Research August 2011PDF, 300 KB
    The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application - Guidance for Industry and ResearchersAugust 2010PDF, 276 KB
 
  • FDA Regulations - Title 21 Code of Federal Regulations:

    Part 50--PROTECTION OF HUMAN SUBJECTSHTML
    Part 56--INSTITUTIONAL REVIEW BOARDSHTML
    Part 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIESHTML
    Part 312--INVESTIGATIONAL NEW DRUG APPLICATIONHTML
    Part 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTSHTML
    Part 511--NEW ANIMAL DRUGS FOR INVESTIGATIONAL USEHTML
    Part 812--INVESTIGATIONAL DEVICE EXEMPTIONSHTML
 
  •  Good Laboratory Practice (GLP) Resources:


    Comparison Chart of FDA, Environmental Protection Agency (EPA), and Organization for Economic Co-operation and Development (OECD)HTMLPDF, 1.8 MB
    Good Laboratory Practice (GLP), Proposed Rule, 11/19/1976HTML N/APDF, 6.2 MB
     Good Laboratory Practice (GLP) Final Rule, 12/22/1978HTML N/APDF, 8.4 MB
    Good Laboratory Practice (GLP), Proposed Rule, 10/29/1984HTMLPDF, 1.8 MB
    Good Laboratory Practice (GLP), Amendment, Final Rule, 9/4/1987HTMLPDF, 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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