Unlawful Stem Cell Products Continue to Harm People as FDA Deadline Looms

Congressional oversight could boost efforts to ensure safe, effective regenerative therapies

Unlawful Stem Cell Products Continue to Harm People as FDA Deadline Looms

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.

Read the remainder of this article at The Hill.

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Biomedical researchers are at the heart of nearly every medical advancement. From cutting-edge cancer treatments to breakthrough discoveries about emerging viruses, these scientists use creativity and ingenuity to explore new horizons in human health and medicine. And for nearly 40 years, The Pew Charitable Trusts has supported more than 1,000 early-career researchers committed to this work.

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