US Food and Drug Administration review divisions are not being pushed to require advisory committee votes or only discussions, just to ensure that staff obtain the input they need to decide on pending applications.
Key Takeaways
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OND Director Peter Stein said advisory committee votes may not be needed if a discussion can elucidate the necessary input.
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Stein also said review staff convinced him a discussion was all that was needed for a recent Antimicrobial Drugs Advisory Committee meeting
As part of advisory committee reform efforts, FDA officials have been writing internal documents outlining best practices for determining when meetings are appropriate and
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