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BIO Comments to FDA on Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development

July 20, 2023

BIO submitted comments on the recent Rare Disease Endpoint Advancement (RDEA) Pilot Program Workshop, held June 7-8, 2023 (Docket No. FDA-2022-N-2480)

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BIO Comments to FDA on Rare Disease Endpoint Advancement Pilot Program Workshop: Novel Endpoints for Rare Disease Drug Development
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We are writing to express our strong support for the bipartisan Optimizing Research Progress Hope and New Cures (ORPHAN Cures Act). The legislation, which was introduced by Reps. John Joyce (R-PA) and Wiley Nickel (D-NC) in September,1 corrects a…
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)