CDER New May 3, 2017

What's New on the FDA Drugs Site

May 2, 2017

• Manual of Policies and Procedures (MAPP) 7500.2 Rev..1 Regulatory Project Management Site Tours and Regulatory Interactions Program (PDF - 41KB) (Recertified)
• Drug Approval Packages
  
  • Bavencio (avelumab) Injection
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Medication Guides Page (Updated)
• National Drug Code Directory
• 503A Category 1 – Bulk Drug Substances Under Evaluation (PDF - 105) (updated)
• 503B Category 1 – Bulk Drug Substances Under Evaluation (PDF - 135) (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)