Elizabeth Lawless

Morgan Lewis

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Latest Posts › Regulatory Reform

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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

FDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients

On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of chemicals in food, including...more

6/30/2025 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Public Comment , Regulatory Reform , Risk Assessment , Risk Management , Supply Chain , Toxic Chemicals

FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community....more

3/3/2025 / Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Health Care Providers , Life Sciences , New Guidance , Patient Access , Pharmaceutical Industry , Regulatory Reform , Regulatory Requirements

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