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Table of Contents
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The Division of Compliance is committed to preventing violations and enforcing the Federal Food, Drug and Cosmetic Act and related laws through guidance, education and regulatory actions. It is comprised of three (3) teams - Bioresearch Monitoring and Administrative Actions; Compliance Information Management; Enforcement and Regulatory Policy
Division of Compliance (HFV-230) Office of Surveillance and Compliance Center for Veterinary Medicine U.S. Food and Drug Administration MPN IV Bldg., Room 146 7519 Standish Place Rockville, MD 20855-2773 Telephone: (240) 276-9200 FAX: (240) 276-9241
Division of Compliance Telephone Directory
Division of Compliance Organization Chart (pdf) (Revised 03/07/2007)
Division of Compliance Resource Contacts List
Bioresearch Monitoring and Administrative Actions Team (BIMO and AA) - HFV-234 - ensures data integrity in premarket approval applications, develops regulatory and enforcement policy related to premarket inquiries, and manages administrative actions.
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Monitors and manages the three Bioresearch Compliance Programs (Sponsor Monitor, Good Laboratory Practice and Clinical Investigator) and all surveillance and compliance activities (e.g., withdrawal of eligibility to receive investigational-use new animal drugs and termination of exemptions) resulting from the administration of these programs.
Compliance Information Management Team (CIMT) - HFV-235 - develops, provides and manages compliance related training programs, information, and systems that meet the needs of our internal and external customers.
Enforcement and Regulatory Policy Team (EARP) - HFV-232 - develops and implements appropriate enforcement strategies and regulatory decisions to ensure the compliance of marketed products.
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Responsible for developing appropriate enforcement strategies for regional, nationwide or import violations (such as Bovine Spongiform Encephalopathy (BSE)), for emerging or expanding compliance problems, and for new regulations related to compliance initiatives.
Web Page Updated by hd - March 8, 2007, 2:51 PM ET
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