Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments
FDA Law Blog
OCTOBER 14, 2024
2014); U.S. Regulatory Background FDA regulates and generally requires premarket approval of all new drugs, which are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” or “intended to affect the structure or any function of the body.” Regenerative Sciences, LLC , 741 F.3d
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