Could MedTech find itself as the collateral damage if an RFK Jr. run HHS “goes wild” with FDA regulation of pharma and ...
Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a ...
EU MDR and IVDR have created many new challenges for medical writing and regulatory affairs professionals. An increased ...
In the face of sweeping Medicare changes for 2025, millions of seniors face the challenge of navigating a complex landscape ...
As laboratories navigate the evolving landscape of Laboratory Developed Tests (LDTs), the FDA’s phased approach to regulation marks a significant shift. This blog outlines what these new regulations ...
Trinity received written notice from the Nasdaq Stock Market LLC (“Nasdaq”) confirming that the Company has regained ...
With numerous planned submissions underway for 2024, the new platform is setting a new standard for managing simultaneous ...
Medical Device reimbursement levels in Japan are now more in line with the reimbursement levels in the EU. The Japanese government has pledged not to allow Japanese device reimbursement to be as high ...