FDA Proposes New Regulatory Framework for Regenerative Medicine

The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on speeding development and clarifying the agency’s enforcement actions over the next three years.

Two final guidances clarify the criteria used to determine whether a product requires agency approval. Meanwhile, two draft guidances describe the expedited review programs available — such as the Regenerative Medicine Advanced Therapy designation, or RMAT, created by 2016’s 21st Century Cures Act — and how devices used in delivering regenerative therapies may be reviewed as combination products.

Commissioner Scott Gottlieb said the field’s rapid growth and complexity presents unique challenges to researchers, providers and the FDA, with more and more products being subject to premarket review.