Drug Discovery & DevelopmentOriginal article
The FDA plans its third rare disease policy change in just over a year
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Summary
On Oct. 14, the FDA announced the Rare Disease Framework Initiative, outlined in a new white paper, to create a fit-for-purpose review approach for rare disease drugs and biologics. The agency says it aims to give developers clearer, more consistent guidance on the evidence needed; this is reportedly its third rare disease policy change in just over a year.
Outcome Details
FDA announced the Rare Disease Framework Initiative, described in a white paper, to build a fit-for-purpose approach to reviewing drugs and biologics for rare diseases.
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FDArare diseaseregulatory policyRare Disease Framework Initiativewhite paper
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Published by Drug Discovery & Development on October 16, 2026 11:10 PM