CDER New October 28, 2015

What's New on the FDA Drugs Site

October 27, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:
  • Product Development Under the Animal Rule Guidance for Industry (PDF - 564KB)
  • Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route
    Guidance for Industry and Review Staff Good Review Practice (PDF - 154KB)
• National Drug Code Directory
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)