What's New Related to Drugs

April 26, 2018

• Medication Guides Page (Updated)
• Clinical Trial Imaging Endpoint Process Standards; Guidance for Industry (PDF - 187KB)
• Drug Approval Packages: 
  • CORPHEDRA (ephedrine sulfate)   
  • ILUMYA (tildrakizumab-asmn)
  • VYXEOS (daunorubicin and cytarabine)
• Manual of Policies and Procedures (MAPP) 5310.3 Rev. 1 Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes (PDF - 86KB)