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FDA rare disease guidance to promote innovation for inherited disorders

March 26, 2026Scott Gottlieb, MD

Scott Gottlieb, MD points to FDA’s new rare disease guidance and argues the agency can build on it to promote innovation for inherited disorders, signaling ongoing policy shaping of rare-disease development pathways.

My article in today's issue of the Journal of the American Medical Association Health Forum, on FDA's new rare disease guidance, and how the agency can build on these policy steps to promote innovation for inherited disorders
Scott Gottlieb, MD
FDArare disease

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