FDA announces new regulatory policies for cell-based therapies

Colony of embryonic stem cells (center), from the H9 cell line. Image credit: Ryddragyn

Colony of embryonic stem cells (center), from the H9 cell line. Image credit: Ryddragyn

Yesterday the FDA announced new regulatory policies for cell-based therapies and regenerative medicine. This action updates the regulatory framework that went into effect in 2005, and is meant to curb the activities of individuals and establishments that make deceptive representations to patients regarding unproven and potentially dangerous therapies.

Using the 21st Century Cures Act as a foundation, FDA issued guidance for a new, streamlined Regenerative Medicine Advanced Therapy (RMAT) process that allows participants to utilize the FDA’s fast track, breakthrough therapy and accelerated approval approaches.