For Emergency Use, US FDA May Visit Rather Than Inspect COVID-19 Vaccine Manufacturing Sites
Agency explains how it will model vaccine authorization process on its licensing process for matters like inspections and lot release.
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Agency outlines plans to authorize variant COVID-19 vaccines and therapeutics based on swift quality assessments.
By focusing on short-term stability, US FDA paves way for quicker emergency use authorization without compromising on quality.
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.