CDER New April 1, 2015

What's New on the FDA Drugs Site

March 31, 2015

• Assessment of the Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs in PDUFA V (PDF - 4MB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug ShortagesNational Drug Code Directory
  • Fomepizole Injection   (Updated - Currently in Shortage)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)