CDER New August 21, 2017

What's New on the FDA Drugs Site

August 18, 2017

• Generic Drug Review Dashboard Report as of July 1, 2017 (PDF - 278KB) 
• FDA D.I.S.C.O.: L-glutamine for sickle cell disease Transcript
• Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)
• Drug Trials Snapshots: MAVYRET
• Identifying Trading Partners Under the Drug Supply Chain Security Act: Guidance for Industry (PDF - 181KB)
• Orange Book (updated)
  • July 2017: Additions and Deletions to the Drug Product List (PDF - 211KB)
  • Orange Book Current Cumulative Supplement (PDF - 1.4MB)
  • Orange Book Data Files (compressed) (ZIP - 641KB)
  • Orange Book Patent Listing Dispute List (PDF - 262KB)
  • Reference Listed Drugs by ANDA Reference Standard List (PDF - 174KB)
• Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (updated)