FDA announces comprehensive regenerative medicine policy framework

08 December 2017
The U.S Food and Drug Administration recently announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. 

Comprising four guidance documents, the framework is intended to balance the agency’s commitment to safety with mechanisms to drive further advances in regenerative medicine so innovators can bring new, effective therapies to patients as quickly and safely as possible.

The first guidance document provides clarity around exceptions of cell and tissue-based products from established regulations. The second clarifies the existing regulatory definitions “minimal manipulation” and “homologous use” and defines actions against unsafe products. 

The remaining two documents are still in the draft phase and discuss how the FDA will evaluate devices used in the recovery, isolation, and delivery of regenerative medicine advanced therapies (RMATs), as well as expedited programs that may be available. 

The overarching goal is to achieve a risk-based and science-based approach to support innovative product development, while clarifying the FDA’s authorities and enforcement priorities and making sure we are protecting patients.