CDER New June 18, 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  

June 17. 2020

• FDA Drug Shortages
  • Ketoprofen Capsules (New - Currently in Shortage)
• Manual of Policies and Procedures
  • MAPP 5232.1 PROCESS FOR THE TRANSFER OF OAI CASES FROM OSIS TO OSI
  • MAPP 5232.2 PROCESS FOR HANDLING OSIS NON-CONCURRENCE WITH DECISION TO DOWNGRADE EIR CLASSIFICATION AT OR AFTER SAM
• Statistical Considerations for Clinical Trials During the COVID-19 Public Health Emergency Guidance for Industry