FDA/ORA Bioresearch Monitoring Information Page |
|
|
|
|
|
|
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 | |
|
-
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) | |