CDER New July 23, 2015

What's New on the FDA Drugs Site

July 22, 2015

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Safety Oversight Board Meeting, May 21, 2015, Public Summary
• Drugs@FDA Data Files (updated)
• FDA Drug Shortages
  • Cefepime Injection (New - Currently in Shortage)
  • Levetiracetam (Keppra) Injection (New - Currently in Shortage)
• Gastroparesis: Clinical Evaluation of Drugs for Treatment Guidance for Industry (PDF - 197KB)
• National Drug Code Directory
• Pediatric Medical, Statistical, and Clinical Pharmacology BPCA and PREA Reviews (updated)
• Pediatric Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act(updated)