Food, Drugs, Healthcare, Life Sciences

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Article
FDA's New "Plausible Mechanism Pathway" And Other Initiatives To Expedite Approval Of Drugs For Ultra-Rare Conditions
Rare and ultra-rare disease product developers face numerous complexities, including in designing and executing clinical trials in very small patient populations, defining and validating endpoints, satisfying the statutory evidentiary standard for product approval, and attracting investment for products with uncertain trajectories.
United States Healthcare
AP
Arnold & Porter
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Article
FDA's New "Plausible Mechanism Pathway" And Other Initiatives To Expedite Approval Of Drugs For Ultra-Rare Conditions
Rare and ultra-rare disease product developers face numerous complexities, including in designing and executing clinical trials in very small patient populations, defining and validating endpoints, satisfying the statutory evidentiary standard for product approval, and attracting investment for products with uncertain trajectories.
United States Healthcare
AP
Arnold & Porter
See more
See more