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FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

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the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

OIG Issues Special Fraud Alert on Medicare Advantage Marketing Arrangements

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

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