CDER New May 19, 2015

What's New on the FDA Drugs Site

May 18, 2015

• FDA Drug Shortages
  • Cefazolin Injection   (Updated - Currently in Shortage)
  • Nalbuphine Hydrochloride (Nubain) Injection   (Updated- Resolved)
  • Piperacillin and Tazobactam (Zosyn) Injection   (Updated - Currently in Shortage)
  • Sodium Phosphate Injection   (Updated - Resolved)
  • Trace Elements   (Updated - Currently in Shortage)
  • Trypan Blue (Membraneblue)   (Updated - Resolved)
• Presentations
  • Applying the Breakthrough Criteria: Oncology, Neurology, Anti-Infective/Psychiatry/Hematology(PDF - 2MB)
  • Breakthrough Therapy Designation: An Analysis of the Past Two and a Half Years (PDF - 1MB)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA Reviews (updated)
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)