CDER New September 7, 2018

September 6, 2018

• FDA Drug Safety Communication: FDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq) (updated)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Trial Snapshots:
  • ANNOVERA
  • GALAFOLD
  • TAKHZYRO
• FDA Drug Shortages
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Ondansetron Hydrochloride Injection (Updated - Currently in Shortage)
• National Drug Code Directory (updated)
• GDUFA Implementation Quarterly Meetings between FDA and Industry  (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)