CDER New January 3, 2017

What's New on the FDA Drugs Site

December 30, 2016

• Bioresearch Monitoring Information System (BMIS) Download
• Bioresearch Monitoring Information System (BMIS) Search
• Clinical Investigator Inspection List (CLIIL) Download
• Clinical Investigator Inspection List (CLIIL) Search
• Drug Approval Packages
  • ADZENYS XR-ODT (amphetamine)
  • Descovy (Emtricitabine/tenofovir alafenamide)
  • Envarsus XR (tacrolimus)
  • ORFADIN (nitisinone)
  • Qbrelis (lisinopril)
  • Soliqua 100/33 (insulin glargine and lixisenatide)
  • TECNTRIQ (atezolizumab)
  • VERMOX (Mebendazole)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Firm Annual Registration Status (updated) 
• Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Guidance for Industry (PDF - 191KB)  
• National Drug Code Directory
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)