Ariel Seeley

Ariel Seeley

Morgan Lewis

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Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

7/7/2025  /  Artificial Intelligence , Department of Health and Human Services (HHS) , Digital Health , Executive Orders , Food and Drug Administration (FDA) , Medical Devices , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

6/10/2025  /  Coronavirus/COVID-19 , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Generic Drugs , Medical Devices , New Guidance , Public Health , Regulatory Reform , Rulemaking Process
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