In the fall of 2024, several pharmaceutical companies reacted to HRSA's decision to prevent them from implementing a rebate model for their respective 340B Programs by filing lawsuits against HHS and HRSA claiming that the...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
4/15/2025
/ Administrative Procedure Act ,
Appeals ,
Centers for Medicare & Medicaid Services (CMS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements ,
Vacated
Summary of Changes - In the fall of 2024, several pharmaceutical companies – specifically, Eli Lilly and Company, Sanofi-Aventis U.S. LLC, Bristol Myers Squibb Company, and Novartis Pharmaceuticals Corporation – reacted to...more
4/2/2025
/ Administrative Procedure Act ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Hospitals ,
HRSA ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Section 340B ,
Statutory Interpretation