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Second Circuit Joins Other Circuits with AKS One Purpose Test

On December 27, 2024, the United States Court of Appeals for the Second Circuit decided United States ex rel. Camburn v. Novartis Pharmaceuticals Corporation and joined a growing list of federal circuit courts that have...more

FDA Issues Draft Guidance on Providing Health Care Providers With Scientific Information on Unapproved Uses of Approved/Cleared...

On Oct. 23, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance in the form of questions and answers (Q&A) regarding manufacturers’ (Firms) dissemination of scientific and medical information on unapproved...more

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