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 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.
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