Rebecca Dandeker

Rebecca Dandeker

Morgan Lewis

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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

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

4/7/2025  /  Biotechnology , Clinical Trials , Drug Pricing , Food and Drug Administration (FDA) , New Guidance , Pharmaceutical Industry , Prescription Drugs , Regulatory Oversight , Regulatory Reform , Regulatory Requirements
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