FDA News: FDA Science, Digital Health Devices, Abuse-Deterrent Opioids, Creative FDA Regulation – Drug and Device Digest

FDA BRIEF: Week of June 12, 2017

2017 FDA Science Forum

FDA Science: Working at the Speed of Emerging Technologies

By: Luciana Borio, M.D.,  Acting Chief Scientist

Innovation is happening extraordinarily fast in biomedical sciences and at FDA

  • FDA’s 11,000 scientists play essential role in advancing biomedical innovations
  • Scientific research presented at Science Forum at FDA
  • Research concentrates on developing knowledge to ensure medical products are safe and effective

2017 Science Forum topics

  1. Identification and Evaluation of New Biomarkers
  2. FDA Response to Urgent Public Health Needs
  3. Microbiome and Human Health
  4. Advanced Manufacturing and 3D Printing
  5. Omics Technologies at FDA
  6. Patient and Consumer Engagement and Communication
  7. Computational Modeling and Simulation at FDA
  8. Current Progress in Nanotechnology Research at FDA

Mobile communications also included

  • Healthy Citizen @FDA to collaborate and communicate with citizens on public health outcomes


Everyone at FDA is committed to focusing on all aspects of the opioid epidemic

New policy steps

  • Steering committee formation to examine regulatory and policy action
  • Evaluate efforts to reduce number of new addiction cases

Abuse-deterrent opioid formulations and public health effect assessment

  • Formulations intended to deter abuse
  • However, effect in a real-world, meaningful decrease of opioid misuse/abuse unknown
  • Public meeting on opioid medications with abuse-deterrent properties to discuss impact of these products in the real world
  • Publicly available issues paper outlining existing regulatory and public health challenges


Sapien 3

By: Jeffrey Shuren, M.D., J.D., and Bram Zuckerman, M.D.

FDA was first to approve Sapien 3 valve interatin to treat high-risk patients with transcatheter valve replacement (TAVR)

  • For high-risk patients with worn out aortic or mitral bioprosthetic valves; Sapien 3 slips into these valves – “valve-in-valve” option
  • FDA Heart Valve Review Team streamlined FDA’s nonclinical testing expectations
  • More consistent, predictable, and transparent about clinical study expectations
  • Industry collaboration on creative clinical trial designs and use of other sources of clinical evidence

Use of real-world evidence for approval

  • Based on Transcatheter Valve Therapy (TVT) Registry, partnership of American College of Cardiology and Society of Thoracic Surgeons
  • Collection of clinical data on TAVR performance both on-label and off-label uses
  • 100,000 TAVR patients since 2011 first approval; >600 patients for off-label, valve-in-valve uses
  • Reliance on real-world evidence to evaluate the benefits and risks of off-label use

FDA working to broaden and improve the opportunities to leverage real-world evidence

  • Establishment of National Evaluation System for health Technology (NEST)
  • Integrate data from clinical registries, electronic health records, and medical billing claims


Image credits: FDA

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