More than two years after the Food and Drug Administration updated its regulatory framework for regenerative medicine, hundreds of businesses continue to sell unapproved stem cell products and other drugs derived from human blood and tissue.
The framework clarified how the agency would oversee the growing market for these products, and it encouraged the development of new therapies while also aiming to restrain the proliferation of unproven—and often dangerous—stem cell treatments.
Businesses were given three years to come into compliance, a period that ends this November. But the FDA has signaled that many clinics and providers have yet to heed approval requirements for their products.
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