US Food and Drug Administration and Regulation Issues for Biologics: The Sands Are Shifting.

چکیده اصلی

Stem cell clinics and stem cell use are arguably subject to regulatory oversight at multiple levels including the US Food and Drug Administration (FDA), offices of attorney generals, and state medical licensing boards. Such regulatory oversight has been enforced unevenly. Two high profile appellate court cases propelled by the FDA, Department of Justice criminal prosecutions, and a US Supreme Court decision have reshuffled the deck, auguring over the next several years paradoxically for both more stringent enforcement and less enforcement.

متن کامل اصلی