Expert Advisor. Advancing Structured Benefit-Risk Assessment in FDA Review. Duke-Margolis. October 4, 2017 - October 4, 2017

Event Attendance

Under a cooperative agreement with FDA, the Duke-Margolis Center for Health Policy is convening this expert workshop to provide stakeholders the opportunity to explore potential quantitative and decision-analytic approaches for evaluating complex review decisions to support structured B-R assessment. The specific objectives for the meeting are to discuss: 1) key considerations for ensuring that B-R analysis tools are fit-for-purpose in FDA’s drug regulatory context, 2) the types of regulatory decisions suitable for implementing analytic B-R approaches, and 3) strategies for incorporating patient input (derived through both qualitative and quantitative methods) into structured B-R assessment. Input from this meeting will support the Agency in its continued efforts to advance and integrate structured benefit-risk assessment in FDA’s human drug review.

Service Performed By

Role

  • Expert Advisor

Date

  • October 4, 2017

Service or Event Name

  • Advancing Structured Benefit-Risk Assessment in FDA Review

Host Organization

  • Duke-Margolis

Location or Venue

  • Washington DC