USA v. California Stem Cell Treatment Center, Inc., et al
Case Number:
22-56014
Court:
Nature of Suit:
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September 27, 2024
9th Circ. Says Stem Cell Treatment Not Exempt From FDA Rule
Two California clinics' experimental stem cell treatments are "drugs" subject to Food, Drug and Cosmetic Act regulations, the Ninth Circuit ruled Friday, reviving the federal government's bid to stop the clinic from marketing the products as cures for certain diseases without U.S. Food and Drug Administration review.
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February 07, 2024
US Tells 9th Circ. Stem Cell Clinic Not Exempt From FDA Rules
The federal government urged a Ninth Circuit panel Wednesday to revive its bid to stop a clinic from offering experimental stem cell treatments, arguing the clinic's procedures are governed by the Food, Drug and Cosmetic Act because they result in a new product that is marketed as a cure for certain diseases.