9th Circuit Finds Stem Cells Are Drugs Under FDCA, Reverses Lower Court

Mealey's ( October 2, 2024, 8:03 AM EDT) -- SAN FRANCISCO — A stem cell mixture used by clinics is a drug under the U.S. Federal Food, Drug, and Cosmetic Act (FDCA), the Ninth Circuit U.S. Court of Appeals ruled in reversing a lower court, also finding that the “same surgical procedure” exception does not apply, though the judges differed on why they reached that conclusion....

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