Life sciences growth · Video
Is FDA’s Off-Label Science Guidance in Effect?
VayoMed Team ·
About this video
Episode 14 examines the status questions documented in VayoMed’s October 2026 SIUU review. It focuses on reconciling records and preserving a communication-specific review across derivative content.
Full transcript
Is FDA's guidance on sharing off-label science actually in effect? The record says two different things.
In January 2025, FDA published its guidance on scientific information on unapproved uses. In 2025, OMB approved both of its information collections. Yet in October 2026, FDA's page still says not for current implementation.
So treat the status as unresolved. Not dead, and not a safe harbor.
Review each communication on its own: the product, the use, the audience, and who asked for it.
Three steps. One: give someone the job of reconciling the status. Two: classify every communication before release. Three: carry the review into every copy, from headlines to distributor pages.
When the status is unclear, document the decision.