CDER New November 29, 2016

What's New on the FDA Drugs Site

November 28, 2016

• Activities Report of the Generic Drug Program (FY 2017) (updated)
• Manual of Policies and Procedures (MAPP) 4301.2  Safety Outcomes Trials Subcommittee (PDF - 74KB)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• Drug Trials Snapshots: XIIDRA
• FDA Drug Shortages
  • Dextrose Injection USP, 70% (Updated - Discontinuation)
• National Drug Code Directory
• Medication Guides Page (updated)
• Providing Postmarketing Periodic Safety Reports in the ICH E2C(R2) Format (Periodic Benefit-Risk Evaluation Report) Guidance for Industry (PDF - 116KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)