CDER New October 27, 2015

What's New on the FDA Drugs Site

October 26, 2015

• Manual of Policies and Procedures (MAPP) 5241.2 Consolidation of ANDAs by the Office of Generic Drugs (PDF - 74KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication: FDA review found no increased cardiovascular risks with Parkinson’s disease drug entacapone
• Guidance for Industry:
  • Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
    Guidance for Industry (PDF - 126KB)
  • Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
    Guidance for Industry (PDF - 105KB)
  • Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance (PDF - 87KB)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)