FDA Finalizes Guidance on Communications Regarding Unapproved Uses of Medical Products

On January 7, the U.S. Food and Drug Administration (FDA) finalized its October 2023 guidance document titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (the final guidance). This guidance finalizes the draft issued in October 2023, and while most of the concepts from the initial draft remain, the final guidance contains several important changes resulting from stakeholder comments. The final…
By: Troutman Pepper Locke