CDER New September 16, 2016

What's New on the FDA Drugs Site

September 15, 2016

• FDA Responses to Action Items From November 16-17, 2015 Inter-governmental Working Meeting on Pharmacy Compounding
• Drug Approval Packages:
  • Seroquel XR 
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Shortages
  • Scopolamine (Transderm Scop) Transdermal System Patch (New - Currently in Shortage)
• Qualification of Biomarker—Total Kidney Volume in Studies for Treatments of Autosomal Dominant Polycystic Kidney Disease Guidance for Industry (PDF - 32KB)
• National Drug Code Directory
• Virtus Pharmaceuticals Opco II, LLC Issues Voluntary Nationwide Recall of Hyoscyamine sulfate Due to Superpotent and Subpotent Results
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)