FDA BRIEF: Week of December 26th, 2016 and January 2nd, 2017


A Review of CDER’s Novel Drug Approvals for 2016

By: John Jenkins, M.D., Director of the Office of New Drugs, CDER 

Approved 22 novel drugs

  • FIRST: Spinal muscular atrophy, Duchenne muscular dystrophy
  • NEW: Hallucinations/delusions in Parkinson’s disease, Primary biliary cirrhosis, Hepatitis C
  • NEW ONCOLOGY: Ovarian cancer, Bladder cancer, Soft tissue sarcoma, Chronic lymphocytic leukemia
  • NEW DIAGNOSTIC AGENTS: Detecting certain forms of cancer

Expedited drug development and review

  • Fast Track designation, Breakthrough Therapy designation, priority review designation, accelerated approval
  • 73%

Met PDUFA goals

  •  95%  “first cycle”
  • 86% first approved in US

However, lower approval rate vs. 2015

  • 22 vs. 45
  • 5 novel drugs approved in in 2015 with 2016 PDUFA dates
  • 14 Complete Response Letters (non-approval) 2016, higher than in recent years

Details in  annual Novel Drugs summary


Managing Medical Device Cybersecurity in the Postmarket: At the Crossroads of Cyber-safety and Advancing Technology


By:  Suzanne B. Schwartz, M.D., M.B.A., Associate Director, Science and Strategic Partnerships, CDRH

Medical device Cybersecurity FDA guidances covering early product development and extending throughout the product’s lifespan

  • FDA has issued final guidance on postmarket cybersecurity
  • Premarket cybersecurity guidance issued in 2014

Importance to medical device community

  • Breaches can affect device’s performance and functionality
  • Need for continuous quality improvement to ensure safety and effectiveness

Recommended steps



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