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FDA Proposes New Approval Pathway for Rare Disease Gene Therapy

Source link : https://newshealth.biz/health-news/fda-proposes-new-approval-pathway-for-rare-disease-gene-therapy/

(MedPage Today) — The FDA on Monday unveiled draft guidance for a new “plausible mechanism” approval pathway for ultra-rare disease treatments. “What is a ‘plausible mechanism’ pathway? It’s common sense,” FDA Commissioner Marty Makary, MD, MPH… Source link : https://www.medpagetoday.com/publichealthpolicy/fdageneral/120010 Author : Publish date : 2026-02-23 22:11:00 Copyright for syndicated content belongs to the linked […]

The post FDA Proposes New Approval Pathway for Rare Disease Gene Therapy first appeared on News Health.

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Author : News Health

Publish date : 2026-02-23 22:11:00

Copyright for syndicated content belongs to the linked Source.

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