What's New on the FDA Drugs Site
May 20, 2016
- Letters (PDUFA) (updated)
- Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act (updated)
- Paragraph IV Patent Certifications (updated)
- Prescription Drug User Fee Act (PDUFA) (updated)
- Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
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