One of many striking things about the US Food and Drug Administration’s 22 October approval of the first COVID-19 therapeutic is how routine the agency action is despite the unusual pressures of the times.
Gilead’s Veklury Approval Shows US FDA’s Existing Regulatory Tools Are Up To The COVID-19 Challenge
The FDA emphasized the rigor of its review of the first COVID-19 therapy, which used few expedited pathways on its way to approval after a two-and-a-half-month review. Post-marketing studies will address remaining concerns about dosing and special populations.
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