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

 
• By Derrick Gingery

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.

vote
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.

As part of advisory committee reform efforts, FDA officials have been writing internal documents outlining best practices for determining when meetings are appropriate and improving the phrasing of discussion and...

Key Takeaways

  • OND Director Peter Stein said advisory committee votes may not be needed if a discussion can elucidate the necessary input.

  • Stein also said review...

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