CDER New November 16, 2017

November 15, 2017

• Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry (PDF - 359KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Safety Communication: FDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
• FDA Drug Shortages
  • Amino Acids (Updated - Currently in Shortage)
  • Lamisil Tablets (New - Discontinuation) 
  • Piperacillin and Tazobactam (Zosyn) Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)