FDA News: Acting Commissioner, Harmonized Benefit/Risk Assessments, Precision Medicine Innovation – Drug and Device Digest

FDA News: Week of January 23, 2017

Meet Stephen Ostroff, M.D., Acting FDA Commissioner 

Stephen Ostroff, M.D., Chief Scientist

Stephen Ostroff, M.D., is the acting Commissioner of Food and Drugs

Prior FDA Appointments

  •  Deputy Commissioner for Foods and Veterinary Medicine
  • Acting FDA Commissioner
  • Chief Scientist
  • Chief Medical Officer

Dr. Ostroff graduated from the University of Pennsylvania School of Medicine in 1981 and completed residencies in internal medicine at the University of Colorado Health Sciences Center and preventive medicine at CDC.



2 comprehensive benefit-risk frameworks for Medical Devices and Drugs, respectively


  • Structured decision-support tools, quantitative and qualitative assessments
  • Consider nature and severity of the condition, magnitude of effect, strength of evidence, other available therapies, applicability ot broader population, postmarket data collection


  • Ways in which uncertainty and patient perspectives are assessed

Considerations for Harmonized Framework:

  • Greater consistency in benefit/risk assessment
  • Reduce variability in decision making; promote transparent regulatory flexibility
  • Promote stakeholder understanding of FDA judgments based on scientific, clinical, and public health considerations
  • Foster increased alignment between FDA and external stakeholders





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