Placeholder Banner

BIO comments to FDA on Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making

June 29, 2023

BIO submitted general comments and proposed changes to FDA (Docket No. FDA-2023-D-0026)

Download Full Comments Below
BIO Comment Letter - FDA2023D0026
Discover More
In response to the agency's request for information (Docket No. FDA-2023-N-0743-0002), BIO provides detailed comments.
BIO provides detailed comments in advance of the July 31, 2023 NIH Workshop, “Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.