Navigating the complexities of maintaining a stable supply chain in an ever-changing global environment is a key focus for FDA-regulated companies. As US policy shifts, the topic of global supply chain has only become more...more
As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more
1/22/2025
/ Artificial Intelligence ,
Centers for Medicare & Medicaid Services (CMS) ,
Cybersecurity ,
False Claims Act (FCA) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Long Term Care Facilities ,
Medical Devices ,
Medicare ,
OIG ,
Patient Privacy Rights ,
Regulatory Requirements ,
Section 340B ,
Telehealth
The U.S. Food and Drug Administration (FDA) issued a final rule on April 29, 2024, that significantly changes the regulatory framework for laboratory developed tests (LDTs). LDTs are in vitro diagnostic products (IVDs) that...more