CDER New April 27, 2016

What's New on the FDA Drugs Site

April 26, 2016

• Public Notifications
  • 3rd Degree contains hidden drug ingredient
  • Black Gold X Advanced contains hidden drug ingredient 
  • Black Label X contains hidden drug ingredient
• CDER Conversation - FDA’s Breakthrough Therapy Designation and Expedited Review Programs: Part II
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Packages
  • Anthim (obiltoxaximab) Injection 
  • Basaglar (insulin glargine) Injection
• FDA Drug Safety Communication: FDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
• Information on Clozapine
• Mechanisms to Improve Awareness and Transparency of Expanded Access Processes and Programs; Public Workshop
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)