Kate Gallin Heffernan

Epstein Becker & Green

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Latest Posts › Medical Devices

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FDA Issues Long-Anticipated Draft Guidance on Diversity Action Plans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

Unpacking Averages: Sample Size for Clinical Trials Used to Obtain FDA Medical Device Clearance

Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more

11/8/2023 / Clinical Trials , FDA Approval , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , Healthcare , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications

FDA Issues Draft Recommendations for Implementing Decentralized Clinical Trials

On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more

6/5/2023 / Clinical Trials , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Medical Research , Pharmaceutical Industry , Prescription Drugs , Telehealth

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