CDER New February 21, 2017

What's New on the FDA Drugs Site

February 17, 2017

• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• National Drug Code Directory
• Orange Book (updated)
  • January 2017: Additions and Deletions to the Drug Product List (PDF - 233KB)
  • Orange Book Current Cumulative Supplement (PDF - 1.8MB)
  • Orange Book Data Files (compressed) (ZIP - 639KB)
• Q11 Development and Manufacture of Drug Substances—Questions and Answers (regarding the selection and justification of starting materials. (PDF - 214KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)