CDER New January 25, 2016

What's New on the FDA Drugs Site

January 22, 2016

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trials Snapshots: VISTOGARD
• FDA works with regulatory partners to understand French-based Biotrial phase 1 clinical study
• GDUFA Reauthorization Negotiation Sessions (updated)
• Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2016 (PDF -47KB)
• National Drug Code Directory
• Warning Letters 2015 (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)