CDER New February 21, 2018

February 23, 2018

• FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy - mp3 file
• FDA D.I.S.C.O.: First FDA approval of a CAR T-cell immunotherapy – Transcript
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated) 
• FDA Drug Shortages
  • Amiodarone Tablets (New - Discontinuation)
  • Asparaginase Erwinia Chrysanthemi (Erwinaze) (Updated - Currently in Shortage)
  • Carbidopa and Levodopa Extended Release Tablets (Updated - Currently in Shortage)
  • Fluoxetine Capsules (New - Discontinuation)
  • Lidocaine Hydrochloride (Xylocaine) Injection (Updated - Currently in Shortage)
  • Triamterene and Hydrochlorothiazide Tablets (New - Discontinuation)
• Hospira Issues A Voluntary Nationwide Recall For Labetalol Hydrochloride Injection, USP, Due To The Potential Of Cracked Glass At The Rim Surface Of The Vials
• National Drug Code Directory (updated)
• Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities  (PDF-843KB)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)