CDER New June 30, 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 29, 2020

• FDA advises consumers not to use hand sanitizer products manufactured by Eskbiochem (Updated)
• FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
• Guidance for Industry:
  • Development of Anti-Infective Drug Products for the Pediatric Population
  • Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry
• Manual of Policies and Procedures (MAPP) 4191.1 Risk Evaluation and Mitigation Strategies Modifications and Revisions