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Drug Approval Standards Drug Review FDA

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

  • Opinion

Executive Summary

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.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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