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Elizabeth Smith advises clients on matters involving Stark Law, False Claims Act, and Anti-Kickback Statute compliance. Elizabeth has defended clients in government investigations related to Medicare and Medicaid billing and has managed due diligence for major hospital transactions, including mergers and acquisitions.

The U.S. Food and Drug Administration (FDA) unveiled a new set of guidelines on August 15, 2023, concerning informed consent, building upon their 2014 draft. The release is a testament to the FDA’s dedication to refining the procedures around clinical trials. In this post, we’re spotlighting the major takeaways from these updates.

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