Son Nguyen

Cooley LLP

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FDA Expands Unannounced Inspections at Foreign Manufacturing Facilities

On May 6, the US Food and Drug Administration (FDA) announced plans to expand its use of unannounced inspections at foreign manufacturing facilities that “produce foods, essential medicines, and other medical products...more

5/14/2025 / Enforcement Actions , Executive Orders , Food and Drug Administration (FDA) , Imports , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements , Supply Chain , Trump Administration

FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim

On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food labels. The new rule uses current nutrition science to both expand and restrict...more

2/12/2025 / Enforcement Actions , Final Rules , Food and Drug Administration (FDA) , Food Safety , Labeling , Nutrition Facts Labels , Public Health , Regulatory Requirements

Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases

Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more

1/31/2025 / Criminal Prosecution , Department of Justice (DOJ) , Enforcement Actions , False Claims Act (FCA) , Food and Drug Administration (FDA) , Fraud , Healthcare Fraud , Medical Devices , Medicare , Physicians

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