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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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.
CBER director said that all the manufacturing data may not be available, but the safety and efficacy data needed for a BLA are expected before an emergency use authorization is granted.