Guidance, Compliance, & Regulatory Information
Popular Items
- Access to Product Samples: The CREATES Act
- Affordable Care Act (ACA 6004)
- "Deemed to be a License” Provision of the BPCI Act
- Human Drug Compounding
- Drug Compliance Programs
- Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products
- FDA Drug Competition Action Plan
- Guidances (Drugs)
- CDER International Program
- Newly Added Guidance Documents
- Product-Specific Recommendations for Generic Drug Development
- Nicotine-Containing Products
- Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials
- Office of Compliance
- The Office of Prescription Drug Promotion (OPDP)
- Prescription Drug Labeling Resources
- Report a Product Quality Issue
- Sunscreen Innovation Act (SIA)
- Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval
- Warning Letters and Notice of Violation Letters to Pharmaceutical Companies
Resources For You
- Compliance Policy Guide, Chapter 4 - Human Drugs
- Manual of Policies & Procedures (CDER)
- Sunscreen Innovation Act (SIA)
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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