CDER New October 28, 2016

What's New on the FDA Drugs Site

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
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
• GDUFA Regulatory Science (updated)