CDER New January 31, 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  

January 30, 2020

• CDER Statement:  FDA revises generic drug application prioritization policy to ensure fairness to applicants, efficiently allocate limited agency resources, and protect the public health
• FDA Drug Shortages
  • Hydroxyzine Pamoate Oral Capsules (Updated - Currently in Shortage)
  • Vincristine Sulfate Injection, USP (Preservative-Free) (Updated - Resolved)
• Manual of Policies and Procedures (MAPP) 5240.3 Rev.5 Prioritization of the Review of Original ANDAs, Amendments, and Supplements
• Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims Guidance for Industry
• Guidance Agenda:  Guidances CDER is Planning to Develop During the Calendar Year 2020