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US FDA draft guidance offers three-factor test to determine when communication about a medical product is consistent with labeling; information on patient-reported outcomes and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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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.
The agency explains that most drug-use-related apps will be considered promotional labeling, but sponsors should sometimes seek advisory comment. US FDA is seeking feedback from a variety of stakeholders on its discussion proposal for regulating prescription-drug-focused software.