CDER New October 31, 2016

What's New on the FDA Drugs Site

October 28, 2016

• Dermatologic and Ophthalmic Drugs Advisory Committee Charter (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Shortages
  • Penicillin G Benzathine (Bicillin L-A) Injection (Updated - Currently in Shortage)
  • Vancomycin HCl Capsules (New - Discontinuation)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)

October 27, 2016

• Drug Approval Packages:
  • Acticlate CAP 
  • Belviq XR 
  • Epclusa 
  • Paricalcitol  
  • Tolak 
• Biosimilars in the US: Progress and Promise Presentation (PDF - 268KB)
• Drug Safety Oversight Board Meeting, May 19, 2016, Public Summary
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated)
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
• GDUFA Regulatory Science (updated)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)