Angela Silva

Angela Silva

Morgan Lewis

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FDA’s AI-Assisted Review: The Next Stage of Regulated Product Evaluation

On June 2, 2025, FDA announced the launch of Elsa, a generative AI tool designed to “help employees—from scientific reviewers to investigators—work more efficiently.” Per FDA, the tool “modernizes agency functions and...more

6/4/2025  /  Artificial Intelligence , Draft Guidance , Food and Drug Administration (FDA) , Machine Learning , Medical Devices , New Guidance , Pharmaceutical Industry , Regulatory Oversight , Regulatory Requirements

Food for Thought Implications of FDAs New Chemical Review Program

The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more

5/29/2025  /  Chemicals , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , New Regulations , Public Health , Regulatory Oversight , Regulatory Reform , Regulatory Requirements , Rulemaking Process

Federal Court Blocks FDA’s Final Rule on LDTs: Key Considerations for Clinical Labs

The US District Court for the Eastern District of Texas issued a pivotal ruling in the consolidated lawsuit American Clinical Laboratory Association v. US Food and Drug Administration (FDA) challenging FDA’s final rule to end...more

4/22/2025  /  Administrative Procedure Act , Centers for Medicare & Medicaid Services (CMS) , Clinical Laboratories , Food and Drug Administration (FDA) , Judicial Authority , Loper Bright Enterprises v Raimondo , Medical Devices , Regulatory Oversight , Regulatory Requirements
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