(MedPage Today) — The FDA on Monday unveiled draft guidance for a new “plausible mechanism” approval pathway for ultra-rare disease treatments.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
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Publish date : 2026-02-23 22:11:00
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