Off-Label Communication: When Does It Align With Approved Labeling?
US FDA draft guidance offers three-factor test to determine when communication about a medical product is consistent with labeling; information on patient-reported outcomes and mechanism of action are okay.
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‘We Don’t Hold Regulatory Actions For Press’ – Inside FDA’s Communications Difficulties And Misinformation Fights
Internal US FDA emails illustrate the difficulties coordinating regulatory decisions and communications about them as the agency considers growing its allies in the war against misinformation.
App allows clinicians to discuss off-label treatments, but information is intended to be hypothesis-generating, not for regulatory use.
For now, FDA is using a case-by-case approach for reviewing and approving expanded access applications asking for off-label uses.