On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
On the heels of recent scrutiny of health care professional (“HCP”) arrangements with brokers and agents and Medicare Advantage Organization (“MAO”) arrangements with providers, including through the U.S. Department of...more