On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to damaged or diseased cells, tissues, or organs. The two final guidance documents outline when cell and tissue-based products would be exempt from the established regulations and clarify how to interpret the definitions of “minimal manipulation” and “homologous use,” concepts used to determine whether a product requires premarket approval. The two draft guidance documents cover how the FDA intends to streamline the regulation of medical devices that are used in regenerative medicine and lay out available pathways to expedited approval.
More notably, the launch represents the latest move in a series of concerted efforts by the FDA to modernize its regulatory approach toward innovative technologies and therapies throughout 2017.
Some notable FDA “firsts” include:
- In April 2017, the FDA approved 23andMe’s genetic health risk tests, the first direct-to-consumer genetic tests to earn market authorization.
- In May 2017, the FDA approved Merck’s Keytruda, the first cancer treatment to be based on a genetic biomarker rather than a tumor location.
- In August 2017, the FDA approved Novartis’s Kymriah, the first cell-based gene therapy to be available in the United States.
Together, the FDA’s efforts demonstrate a strong commitment to remain current and to navigate medical advances that fail to fit within the agency’s traditional approach to regulation. These efforts are motivated on two fronts: to facilitate efficient pathways that bring novel therapies to consumers as quickly and safely as possible and to deter “unscrupulous actors” from taking advantage of the clinical promise surrounding modern medicine.
With medical innovation growing at an increasingly rapid pace, we anticipate even more “firsts” from the FDA in 2018.
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