District Court Embraces Loper Bright and Overturns FDA Laboratory Developed Test Rule – What Lies Ahead?
By EsqSocial Corporation 10/04/25
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), a closely watched case that consolidated two sets of challenges to the validity of FDA’s final rule on the regulation of laboratory developed tests (“LDTs”). Citing the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, the court found that FDA lacked statutory authority to regulate...
By: Ropes & Gray LLP