CDER New December 9, 2015

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What's New on the FDA Drugs Site

December 8, 2015 

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA approves first drug to treat a rare enzyme disorder in pediatric and adult patients
• FDA Drug Shortages
  • Leucovorin Calcium Lyophilized Powder for Injection   (Updated - Currently in Shortage)
  • Levetiracetam (Keppra) Injection   (Updated - Currently in Shortage)
  • Vancomycin Hydrochloride for Injection, USP   (Updated - Currently in Shortage)
• Frequently Asked Questions on the Orange Book (updated)
• Manual of Policies and Procedures (MAPP) 4658.3 Rev.3 Requesting New Full-Time Equivalents (PDF - 657KB)
• Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
• National Drug Code Directory
• Regulatory Pharmaceutical Fellowship (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)