On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
5/24/2024
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Covered Entities ,
Department of Health and Human Services (HHS) ,
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Pharmaceutical Industry ,
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Prescription Drugs ,
Section 340B
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to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
10/25/2023
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Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Healthcare Reform ,
Labeling ,
Medical Devices ,
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Regulatory Requirements ,
Regulatory Standards