The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Podcast: Direct Access Laboratory Testing: Reimbursement & Compliance – Diagnosing Health Care
COVID Laboratory Testing Investigations
Similar to other types of healthcare entities, clinical laboratories have been facing enhanced scrutiny from federal authorities over the past couple of years. While this is due in part to fraud concerns related to COVID-19...more
Commercial establishments where alcoholic beverages are served (e.g., bars, restaurants) and social hosts who serve alcohol in non-commercial settings may find themselves potentially liable for damage, injury, and/or death...more
Our FDA Compliance & Enforcement Team reviews how the Food and Drug Administration’s first guidance on nitrosamine impurities shows what the FDA has learned about the sources of such impurities and what manufacturers can do...more