What's New Related to Drugs

December 18, 2019

• Human Drug Imports (updated) | Human Drug Exports (new)
  • Pre-launch activities importation request (PLAIR) frequently asked questions (updated)
  • Certificates of Pharmaceutical Product: General (updated) 
  • Human Drug Export Certificate Application Instructions (updated)
• Public Notifications:
  • U-Dream Full Night contains hidden drug ingredient
  • U-Dream Lite contains hidden drug ingredient
• Bridging for Drug-Device and Biologic-Device Combination Products Guidance for Industry
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• FDA Drug Shortages
  • Buspirone HCl Tablets (Updated - Currently in Shortage)
  • Trifluridine Ophthalmic Solution (Updated - Currently in Shortage)
  • Valsartan Tablets (Updated - Currently in Shortage)
• Manual of Policies and Procedures (MAPP) 6702.1 Risk Evaluation and Mitigation Strategy (REMS) Assessment
• National Drug Code Directory (updated)
• NDC Unfinished Drugs Excluded Database File (updated) 
• NDC Database Excluded Packages and Products (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)