CDER New November 18, 2016

What's New on the FDA Drugs Site

November 17, 2016

• BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry (PDF - 178KB)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• FDA approves Intrarosa (prasterone) for postmenopausal women experiencing pain during sex
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Zofran Oral Solution (New - Discontinuation)
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)