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Newsletter - September 1, 2022

Court Rules Autologous Stem Cell Therapy Legal in a Rebuke to the FDA

In a stunning decision against the FDA, the United States District Court for the Central District of California ruled this week that autologous fat stem cell products cannot be regulated as new drugs. The ruling contains several comments by the court that upend about two decades of FDA’s regulatory decisions and several...Read More

Who Will Regulate Stem Cell Therapy Clinics Now that FDA Can’t?                                                                                                             
This week’s court ruling to deregulate the most common form of autologous stem cell therapies would allow clinics to openly offer these treatments without the fear of FDA. The court, however, only ruled in favor of the medical practice but not the marketing claims made by the providers to lure their patients to opt...Read More

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