A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA
By EsqSocial Corporation 11/04/25
The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology, in the Eastern District of Texas to determine whether the Federal Food, Drug, and Cosmetic Act (FD&C Act) permits the agency to regulate laboratory developed tests (LDTs) is a complete victory for clinical laboratories......
By: Mintz - Health Care Viewpoints