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FDA announces guidelines that could hasten review of regenerative medicine products, such as stem cells

November 27, 2017

By Michelle Manchir

Silver Spring, Md. — The U.S. Food and Drug Administration announced Nov. 16 that it was issuing a new policy framework that could get treatments involving human cells and tissues, such as stem cells, available for patients faster — while also stepping up enforcement against products that raise safety concerns.

“We’re adopting a risk-based and science-based approach that builds upon existing regulations to support innovative product development while clarifying the FDA’s authorities and enforcement priorities,” said Scott Gottlieb, M.D., FDA commissioner, in a news release. “This will protect patients from products that pose potential significant risks, while accelerating access to safe and effective new therapies.”

To see the full announcement, visit FDA.gov and search for “FDA announces comprehensive regenerative medicine policy framework.”

Relatedly, in a communication to consumers updated in November, the FDA offered insight about the use of stem cells as a treatment of medical conditions.

The administration said while stem cell therapies “may offer the potential to treat disease or conditions for which few treatments exists,” the only stem cell-based products that are currently FDA-approved for use in the U.S. consist of blood-forming stem cells derived from cord blood.

The FDA in its consumer update urged consumers to ensure any stem cell treatment they seek is FDA-approved or being studied under an investigational new drug application, or a clinical investigation plan submitted and allowed to proceed by the FDA.

To see the full consumer update from the FDA, visit FDA.gov and search for “FDA Warns About Stem Cell Therapies.”

Earlier this year, concern about the long-term genetic stability of stem cells was covered in a Science in the News article looking at cultured human embryonic stem cells used to treat disease.  To access the Science in the News article, visit ADA.org.