Drugs
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Guidance, Compliance, & Regulatory Information
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Popular Items
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Biologics Price Competition and Innovation Act of 2009 -
Drug Compliance Programs -
Guidances (Drugs) -
Newly Added Guidance Documents -
Bioequivalence Recommendations for Specific Products -
Office of Compliance -
The Office of Prescription Drug Promotion (OPDP) -
Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials -
Regulatory Guidance Drug Registration and Listing -
Unapproved Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval -
Warning Letters and Notice of Violation Letters to Pharmaceutical Companies -
Affordable Care Act (ACA 6004)
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Contact FDA
Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
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