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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Toll Free
(855) 543-3784
(301) 796-3400
Hours Available
Center for Drug Evaluation and Research (CDER)