CDER New March 1, 2016

What's New on the FDA Drugs Site

February 29, 2016

• CDER Data Standards Program (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• From our perspective: Encouraging drug development for rare diseases
• FDA Drug Shortages
  • Aprepitant (Emend) Capsules   (Updated - Resolved)
• National Drug Code Directory
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry (PDF - 85KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)