CDER New July 21, 2020

Updated Monday through Friday

• Drug Firm Annual Registration Status
• Drug Firm Annual Registration Status Download File 
• National Drug Code Directory
• NDC Unfinished Drugs Excluded Database File 
• NDC Database Excluded Packages and Products 
• Wholesale Distributor and Third-Party Logistics Providers Reporting  

July 20, 2020

• CDER Patient-Focused Drug Development
• CDER Conversations
  • Building on Successes of the Generic Drug Program, FDA Sets the Stage for the Next Generic Drug User Fee Amendments (GDUFA) Reauthorization Process
  • New Funding Opportunity: FDA Standard Core Clinical Outcome Assessments (COAs) and Endpoints Pilot Grant Program
• FDA Drug Shortages
  • Deferasirox Tablets (New - Discontinuation)
  • Ketamine Injection (Updated - Currently in Shortage)