Litigation of unlicensed US stem cell products.

Lee, Branden; Brookes, Noah; Levin, Adam S · Cell Stem Cell · 2025

review · Level V

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Abstract

Financial dispositions against unapproved stem cell interventions have grown significantly, with successful class-action lawsuits, malpractice claims, and collaborative prosecutions between government agencies. In addition to improved dispositions, federal circuit courts have given unanimous affirmation to the FDA's regulatory authority over stem cell interventions, establishing critical precedents for oversight.

Medical subject headings