Food, Drugs, Healthcare, Life Sciences

In an unexpected move, the Virginia legislature elected not to expand the liability and exposure of Virginia hospitals and health systems.

The FDA has sent reminder letters to over 2,200 drug, biologic, and medical device companies regarding potential failures to publish required clinical trial results on ClinicalTrials.gov.

Federal enforcement of Medicare and Medicaid fraud has intensified dramatically, with recent prosecutions involving billions in alleged losses and sophisticated data analytics. Recent Sixth Circuit decisions reveal critical compliance vulnerabilities in medical necessity documentation, billing practices, and compensation structures that can trigger both criminal prosecution and civil False Claims Act liability.