Resources
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FDA CDER Contact Information
- Phone: (888) 463-6332
- Phone: (301) 796-3400
- Email: druginfo@fda.hhs.gov
- Address:
Division of Drug Information (CDER)
Office of Communications
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20903
Links
- Orange Book
- Roche Products v. Bolar Pharmaceutical
- Residual Solvents in ANDAs: Questions and Answers
- Q1A(R2) Stability Testing of New Drug Substances and Products
- Q3A Impurities in New Drug Substances
- Q3B(R2) Impurities in New Drug Products
- Q3C Impurities: Residual Solvents
- Review Order of Original ANDAs, Amendments, and Supplement
- Post-Approval Studies -- Frequently Asked Questions
- Office of Generic Drugs
- Question-Based Review for CMC Evaluations of ANDAs