The U.S. Food and Drug Administration's (FDA) recent announcement of a final rule extending regulatory oversight to laboratory developed tests (LDTs) has sparked controversy. As discussed in a previous Holland & Knight alert,...more
5/6/2024
/ American Hospital Association ,
CLIA ,
Clinical Laboratories ,
Exemptions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Regulatory Requirements
Envision Healthcare Corp. and certain of its wholly owned subsidiaries (Envision) recently filed voluntary Chapter 11 petitions in the U.S. Bankruptcy Court for the Southern District of Texas (Bankruptcy Court). In re:...more