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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)

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BIO Comment Letter - FDA2023D0026
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The Council of State Bioscience Associations wrote House and Senate leaders to urge support of H.R. 5539 and S. 3131, the Optimizing Research Progress Hope and New Cures Act. 
BIO provided general comments and recommended edits Re: FDA-2023-D-3031