Guidance, Compliance, & Regulatory Information
Popular Items
- Drug Compliance Programs
- Pharmaceutical Inspections and Compliance
- Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products
- FDA Drug Competition Action Plan
- FDA’s Labeling Resources for Human Prescription Drugs
- Guidance Documents
- Product-Specific Recommendations for Generic Drug Development
- Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials
- Office of Compliance
- The Office of Prescription Drug Promotion (OPDP)
- Report a Product Quality Issue
- Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Resources
- Compliance Policy Guide, Chapter 4 - Human Drugs
- Manual of Policies & Procedures (CDER)
- Sunscreen Innovation Act (SIA)
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Contact FDA
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Contact FDA
Contact Point
Office of Communications
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
10001 New Hampshire Ave
Hillandale Building, 4th Fl
Silver Spring, MD 20993
Toll Free
(855) 543-3784
(301) 796-3400
Hours Available
CDER Division of Drug Information