The FDA will host a public workshop on Benefit-Risk for decision-making in drug development on the 18th of September.

This meeting will focus on:

  • Regulatory and industry experiences with approaches to structured benefit-risk assessments.
  • Approaches to incorporating patient perspectives into structured benefit-risk assessment.
  • Exploration of methods to advance structured benefit-risk assessment.

The workshop is free and can be attended in person or through a webcast (details on how to register can be found in the link above).

Event: FDA will host public free workshop on benefit-risk