CDER New August 28, 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  

August 26, 2020

• Manual of Policies and Procedures (MAPP) 5242.1 Transfer of Ownership
• FDA Drug Safety Communication: FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
• CDER Statement: FDA works to mitigate shortages of rifampin and rifapentine after manufacturers find nitrosamine impurities