Can US FDA Regulate Stem Cell Transplantation? Court Says Question Must Go To Trial
Court denies FDA request for summary judgement in suit against two clinics treating patients with cells derived from their fat tissue; trial to determine whether exception to FDA regulation applies.
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Federal court rules that US Stem Cell in Florida must halt injections of stem cell products until the company obtains licenses from the US FDA to market them and demonstrates compliance with drug GMP requirements. This action follows numerous adverse events associated with these product; several patients experienced vision loss after eye injections.
Plaintiff Peter Lurie, former US FDA associate commissioner, expects results of hundreds of clinical trials of approved drugs will become available under ruling against HHS; co-plaintiff sought eteplirsen study data.