A Pandemic Template For Swift Approval? Veklury Stability Questions Deferred For Later Study
The US FDA shaved months from review of Gilead’s Veklury (remdesivir) for COVID-19 with post-approval commitments for multiple stability studies. The Pink Sheet takes a deep dive look at discussions within the agency and with the sponsor.
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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.
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.
When the coronavirus hit China, Gilead only had enough remdesivir for 5,000 patients. Here’s how it went about expanding production.