US FDA’s Opaque Galafold Review: A Rare Misstep In The Trump Era

 
• By Michael McCaughan

When FDA reversed course and allowed Amicus to file for Accelerated Approval of migalastat, plenty of people suspected politics were at play. The agency's handling of the review won’t do anything to allay those suspicions.

Galafolds' heavily redacted cardio-renal consult review
What's the whole story of the Galafolds review?

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