Olivia Plinio

Olivia Plinio

Epstein Becker & Green

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FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans

The Food and Drug Omnibus Reform Act of 2022 (“FDORA” or the “Act”), signed into law on December 29, 2022, required, in part, drug and device manufacturers to submit Diversity Action Plans to the U.S. Food and Drug...more

7/10/2024  /  Clinical Trials , Diversity , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Pharmaceutical Industry , Prescription Drugs

Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: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