Delia Deschaine

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U.S. Government Shutdown 2025 (Week 1): Early Insights into FDA Operations

By Delia Deschaine, John Wyand and Xiaomei Cai on October 13, 2025 Posted in Events, FDA

The 2025 U.S. government shutdown kicked in effective at 12:01am, October 1, 2025, and as of this posting, has been in place for over a week. The shutdown will continue indefinitely until Congress unifies and resolves the budget impasse. The U.S. Food and Drug Administration (“FDA”), tasked with protecting public health by ensuring the safety, … Continue Reading

District Court Strikes Down FDA’s LDT Rule, Opens the Door for Challenges to FDA’s Regulation of Other “Services” as Medical Devices

By Keith Bradley, Delia Deschaine and Samuel Ballingrud on April 11, 2025 Posted in FDA, Regulations

On Monday, March 31, a court in the Eastern District of Texas found unlawful and vacated the Food and Drug Administration’s 2024 Rule regulating as “devices” under the Food, Drug, and Cosmetic Act (“FDCA”), certain laboratory-developed test (“LDTs”) used to diagnose, monitor, or determine treatment for diseases and conditions. The decision, American Clinical Laboratory Assoc. v. … Continue Reading