CDER New July 26, 2017

What's New on the FDA Drugs Site

July 25, 2017

• Biosimilar User Fee Act (BsUFA) (updated)
• FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) (Update) 
• Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.): Two approvals for ALK-positive non-small cell lung cancer
• Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry (PDF - 91KB)
• Drug Firm Annual Registration Status (updated)
• Drug Firm Annual Registration Status Download File (updated)
• Drug Approval Package:  
  • Baxdela (delafloxacin) Tablets and Injection
  • Bevyxxa Capsule
• Generic Drug User Fee Amendments of 2012: Questions and Answers Related to Self-Identification of Facilities, Review of Generic Drug Submissions, and Inspections and Compliance Guidance for Industry (PDF - 132KB)
• National Drug Code Directory
• Prescription Drug User Fee Act (PDUFA) (updated)
• Wholesale Distributor and Third-Party Logistics Providers Reporting (updated)