FDA VOICE: CDER 2016 Approvals, Medical Device Cybersecurity
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
- Monitor/detect vulnerabilities
- Assess/detect risks to patient safety
- Receive additional information from research communities
- Proactively deploy mitigations
- Apply National Institute of Standards and Technology’s (NIST) core principles for improving critical infrastructure cybersecurity