Stability Genius: How CMC Section Of COVID-19 Vaccine Guidance Speeds EUAs Safely
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.
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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.
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.
US, EU and Canadian authorities recently discussed their approaches to rolling reviews of CMC applications for coronavirus vaccines.