CDER New September 25, 2018

September 24, 2018

• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Guidance for Industry:
  • Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications (PDF - 98KB)
  • ANDA Submissions — Content and Format of Abbreviated New Drug Applications (PDF - 833KB) 
• National Drug Code Directory (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)