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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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.
Among the differences between the emergency use authorizations is that manufacturing quality requirements will apply to Gilead’s remdesivir, while chloroquine and hydroxychloroquine received blanket waivers as part of their EUA from the US FDA.