Articles and Blogs

On March 31, 2025, the U.S. District Court for the Eastern District of Texas (District Court) struck down the U.S. Food and Drug Administration’s (“FDA” or “Agency”) Final Rule that would have asserted FDA’s authority to regulate laboratory-developed tests (“LDTs”) as medical devices under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) (“LDT... READ MORE

Pharmacogenetic Testing and the FDA’s 2018 Warning The advent of direct-to-consumer genetic testing has yielded an explosion in the development of various types of genetic tests for clinical treatment and diagnostic purposes. These tests include pharmacogenetic tests, which are used to better understand the role genetics play in an individual patient’s reaction to certain... READ MORE