Wyatt Kernell

Wyatt Kernell

Cooley LLP

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Latest Posts › Food and Drug Administration (FDA)

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FDA's Draft Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

On July 8, 2024, the Food and Drug Administration (FDA) released updated draft guidance, “Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers,” that replaces similar guidance from...more

9/9/2024  /  Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA’s Latest Twist on Digital Health Oversight Brings Big Shift

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable assurance of safety and effectiveness...more

1/3/2023  /  Digital Health , Food and Drug Administration (FDA) , Medical Devices , Medical Software , Popular , Software
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