Bonnie Odom

Bonnie Odom

Epstein Becker & Green

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Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more

11/21/2023  /  Food and Drug Administration (FDA) , Health Care Providers , Healthcare , Information Sharing , Life Sciences , Medical Devices , Pharmaceutical Industry

Congress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs

On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which...more

1/20/2023  /  Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs
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