COVID-19 Vaccine EUA Process Compresses Advisory Committee Prep Too

 
• By Derrick Gingery

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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Sponsors must include advisory committee presenter slides, as well as meeting briefing materials, with their coronavirus vaccine EUA request. • Source: Shutterstock

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