FDA Biologics (BLA & Biosimilars)Original article
RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations - 09/29/2026
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Summary
The FDA Rare Disease Innovation Hub and Duke Margolis will host a public workshop on September 29, 2026, to discuss statistical considerations for rare disease clinical trial design, conduct, and analysis.
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rare diseaseclinical trial designregulatory guidanceworkshop
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Published by FDA Biologics (BLA & Biosimilars) on September 14, 2026 3:50 PM