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The Food and Drug Administration on Thursday unveiled a series of guidelines that aim to encourage the development of promising and legitimate stem cell therapies while distinguishing them from the largely untested stem cell treatments hawked by unregulated clinics around the country.
The FDA’s guidelines have been expected and eagerly awaited by the stem cell community given the rapid proliferation of untested — and potentially unsafe — therapies around the country. Clinics promoting these therapies claim to be able to treat ailments from autism to neurodegenerative disorders to erectile dysfunction.
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The guidelines also spell out how the agency will implement the regenerative medicine provisions in a behemoth law enacted last year called the 21st Century Cures Act.
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