Off-Label Communications: Industry, FDA Debate Role Of Peer Review
Allowing manufacturers to share research on unapproved uses that has not been formally vetted and published raises transparency concerns, US FDA commissioner says; industry attorney counters that many useful data sources 'would never see the light of day' under current peer review approaches.
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Sponsors and payers question guidances' scope and potential audiences, and wonder if the agency couldn't just perform some retrospective audits of off-label communication to speed things up.