CDER New March 8, 2016

What's New on the FDA Drugs Site

March 7, 2016

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Manual of Policies and Procedures (MAPP)
  • 4200.5 Transfer of CDER Central Funds to Support Intercenter Science Projects (PDF - 2.5MB)
  • 5223.2 Scoring Configuration of Generic Drug Products (PDF - 79KB)
• National Drug Code Directory
• Sagent Pharmaceuticals Initiates a Nationwide Voluntary Recall of Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg per 100ml Due to the Discovery of an Out of Specification Impurity Result Detected During Routine Quality Testing of Stability Samples at the 18-Month Interval
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)