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FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

President Biden Issues Executive Order on Use of Artificial Intelligence in Healthcare Settings

On October 30, 2023, President Biden issued an executive order (EO) to guide federal agencies on the development and use of artificial intelligence (AI). The administration views AI as holding numerous benefits but at the...more

FDA Issues Revised Draft Guidance on “Scientific Information on Unapproved Uses Communications”

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more

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