Judge Blocks FDA Regulation of Laboratory-Developed Tests
By EsqSocial Corporation 28/04/25
On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed tests ("LDTs"). The court found that the Final Rule exceeded the FDA's authority under the Federal Food, Drug, and Cosmetic Act ("FDCA")....
By: Jones Day