COVID-19 Vaccine EUA Process Compresses Advisory Committee Prep Too
US FDA wants briefing documents when EUA is submitted to accommodate timely advisory committee reviews; unlike traditional assessment process, the agency does not appear interested in engaging in back-and-forth discussions with sponsors about portions of the briefing document that should be made public or redacted.
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With strong data from Moderna and Pfizer, the projection for an EUA by the end of 2020 still may hold despite holidays and other obstacles to completing the necessary work.
US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as much safety data follow-up as a typical vaccine licensed under a BLA, says CBER director Peter Marks.
With the meetings available on television, access can be assured for just about everyone, and the US FDA can avoid another gut punch to its credibility.