FDA, Public Health and State Policy - Health Care Compliance Brief

FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

Hall Render

JANUARY 30, 2025

This guidance finalizes FDAs revised draft issued in October 2023 , which updated and replaced the 2014 and 2009 draft guidance documents. A statement disclosing FDA-approved use(s) of the medical product, including any limitations of use specified in the FDA-required labeling. Before the U.S.

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Health Care Compliance Brief

FDA Issues Final Guidance on Communications About Unapproved Uses of Medical Products

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