Close

A Lifecycle Approach to FDA’s Structured Benefit-Risk Assessment Framework

This White Paper was developed by the Structured Benefit-Risk Working Group of the Biotechnology Industry Organization (BIO). The paper identifies considerations for biopharmaceutical companies who choose to use FDA’s Structured Benefit-Risk Assessment Framework earlier and more broadly throughout a product’s lifecycle as a mechanism to both solicit patient perspectives on areas of unmet medical need and assess patient preferences, and to align with FDA on key benefit-risk considerations.

DOWNLOAD THE WHITE PAPER