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Compliance Program Guidance Manual
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FDA’s Compliance Programs provide instructions to FDA personnel for conducting activities to
evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws
administered by FDA. Compliance Programs are made available to the public under the Freedom of
Information Act. (See FDA Freedom of Information Act Handbook for Requesting Information and
Records from FDA.)
Compliance Programs do not create or confer any rights for or on any person and do not operate to
bind FDA or the public. An alternative approach may be used as long as the approach satisfies the
requirements of the applicable statutes and regulations. FDA's Compliance Programs are organized
by the following program areas:
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Biologics (CBER)
Bioresearch Monitoring (BIMO)
Devices/Radiological Health (CDRH)
Drugs (CDER)
Food and Cosmetics (CFSAN))
Veterinary Medicine (CVM)
More in Compliance Program Guidance Manual
Page Last Updated: 03/20/2015
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