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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

The FDA's Response to AI Medical Innovation — The Good Bot Podcast [Audio]

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Judy O'Grady and Associate...more

FDA Issues New Draft Guidance for Unapproved Use Communications

On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more

HHS Waives HIPAA Sanctions To Facilitate Suppression Of Coronavirus

Following declarations of a public health emergency by President Trump and the Secretary of the Department of Health and Human Services (HHS), HHS continues to loosen legal restrictions in an effort to mitigate harm from the...more

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