May 2017 – Drug and Device Digest

FDA News: Forceful steps for Opioid Crisis, Cybersecurity Workshop

FDA BRIEF: Week of May 22, 2017


FDA Commissioner Asks Staff for ‘More Forceful Steps’ to Stem the Opioid Crisis

By: Scott Gottlieb, M.D., Commissioner. @SGottliebFDA

Dr. Scott Gottlieb

Highest initial priority is reduce epidemic of opioid addiction; Establishing Opioid Steering Committee

  • Explore and develop additional FDA tools to answer following questions
  • ? Mandatory education for health care professionals: appropriate prescribing recommendations, identify abuse risk, treat addicted patients
  • ? Additional risk management to tailor prescription of opioid doses
  • ? Proper policy framework  for risk of abuse and misuse


Public Workshop – Cybersecurity of Medical Devices: A Regulatory Science Gap Analysis

Hosted by FDA, National Science Foundation (NSF) and Department of Homeland Security, Science and Technology (DHS, S&T)


  • Examine opportunities for FDA engagement with new and ongoing research
  • Catalyze collaboration among stakeholders to identify regulatory science challenges
  • Discuss innovative strategies to address those challenges
  • Encourage proactive development of analytical tools, processes, and best practices





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