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On April 29, 2024, the FDA announced a final rule that amends the FDA regulations to bring laboratory developed tests (LDTs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). While much of the industry scrambles to understand the implications, manufacturers will find the new rule provides a significant opportunity for LDT device...
The healthcare ecosystem has been rapidly evolving over the past few decades, and it seems to be accelerating. Developing more cost-effective methods of addressing chronic diseases, such as cardiac-related illness, is a high priority. The fairly recent evolution of Patient Support Programs (PSP) is increasingly seen as having the potential to address this need. ...