‘Who Is The Arbiter?’ US FDA Asks As It Mulls Loosening Off-Label Reins
A drumbeat of court cases – and now a change in presidential administrations – signals that regulations on off-label communications need to change; but FDA still seems unsure how to relax its grip without letting go completely.
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Off-Label Wish List: Industry Groups Want US FDA's Guidances To Do More
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.
Off-Label Communication Growth: Could FDA Afford To Police It?
Another user fee for the US drug agency could help pay for research of off-label uses, but lack of resources could be a regulatory problem.
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.