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Fast-track approval system flawed, FDA report says

Allison Torres Burtka

In a preliminary report on the fast-track review process that resulted in FDA approval of the Menaflex knee-repair implant, the agency found that political pressures affected decision-makers and that the process lacks transparency, documentation, and clear procedures. The breakdown in the system constituted “a clear deviation from processes needed to support scientific integrity," the report concluded.

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