Adcomm Reform: Getting Needed Information More Important Than Vote Or Discussion

US FDA Office of New Drugs Director Peter Stein says review divisions have made the case that a discussion-only meeting would solicit the necessary input.

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Voting is largely a means to solicit adcomm member thinking, OND Director Peter Stein said. • Source: Shutterstock

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.

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