Elizabeth Mulkey, Sukrti Thonse, Carrie Clowney, Susan Lee, Author at Life Sciences Perspectives

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Elizabeth Mulkey, Sukrti Thonse, Carrie Clowney, Susan Lee, Author at Life Sciences Perspectives

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How to (Finally) Get Your SIUU Out: FDA Issues Final Guidance on Communicating Off-Label Scientific Information

On January 7, 2025, FDA announced the availability of a final guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” The final guidance supersedes the agency’s revised draft guidance of the same title issued in October 2023 (see our…