CDER New May 13, 2015

What's New on the FDA Drugs Site

May 12, 2015

• CDER Formal Dispute Resolution 
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Dexamethasone Sodium Phosphate Injection   (Updated - Currently in Shortage)
  • Fomepizole Injection   (Updated - Currently in Shortage)
  • Irrigation Solutions  (Updated - Resolved)
  • Sterile Water for Injection Solutions  (Updated - Resolved)
  • Tobramycin Injection   (Updated - Currently in Shortage)
• Guidance for Industry:
  • Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment (PDF - 179KB)
  • Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 (PDF - 104KB)
• National Drug Code Directory
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)