Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Episode 18 | Unpacking the Packing: A Perspective on the Efforts to Expand the Supreme Court
Over the weekend, the Department of Justice (DOJ) did not file an appeal of the U.S. District Court for the Eastern District of Texas’ decision to vacate and set aside the agency’s final rule on the regulation of laboratory...more
The CFPB's 2024 final rule on credit card late fees has been vacated as a result of the lawsuit filed by several banking industry trade groups challenging the rule’s validity....more
On April 15, 2025, the U.S. District Court for the Northern District of Texas vacated a Consumer Financial Protection Bureau (CFPB) rule that capped credit card late fees at $8....more
On April 15, Judge Mark T. Pittman of the U.S. District Court for the Northern District of Texas entered an Order and Final Judgement vacating the CFPB’s 2024 credit card late fee rule (previously discussed here) for...more
On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more
On April 7, 2025, Judge Matthew Kacsmaryk of the Northern District of Texas vacated two provisions of a major 2024 CMS nurse staffing regulation requiring nursing homes to have an RN on site 24 hours a day, 7 days per week...more
The Consumer Financial Protection Bureau (CFPB or Bureau) agreed to vacate its controversial credit card late fee rule in a joint motion for entry of consent judgment filed in Chamber of Commerce of the United States of...more
The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more
On April 7, 2025, the United States District Court for the Northern District of Texas vacated staffing requirements published in the Centers for Medicare & Medicaid Services (CMS) May 2024 Minimum Staffing Rule (the “Final...more
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,...more
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. Judge Jordan’s decision vacates and sets...more
A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
In this edition of Insights, we take a closer look at the megadeals and sponsor transactions driving recent M&A activity, the importance of staying ahead of the risks in AI development and deployment, and other diverse...more