Brianna Alunni

Brianna Alunni

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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...more

1/23/2025  /  Final Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Medical Devices , Pharmaceutical Industry , Regulatory Requirements , Scientific Research

FDA Issues New Draft Guidance for Unapproved Use Communications

On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

10/26/2023  /  Draft Guidance , Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Life Sciences , Manufacturers , Medical Devices , Patient Privacy Rights , Pharmaceutical Industry
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