CDER New January 19, 2017

What's New on the FDA Drugs Site

 January 18, 2017

• Regulatory Pharmaceutical Fellowship (updated)
• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff (PDF - 609KB)
• Drug Approval Packages
  • Spinraza (nusinersen) Injection
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Epinephrine Injection (Updated - Currently in Shortage)
  • Nitrous Oxide, Gas (New- Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 4643.8 Relocation Program (PDF - 266KB)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)