The US Food and Drug Administration, the mechanism of action, and other considerations for cell-based therapy candidates

The focus of this Commentary is to introduce cell-based therapy in the context of how I believe the U.S. Food and Drug Administration (FDA) might establish criteria for the approval of clinical trials that could eventually lead to the final marketplace approval of these medically relevant, cell-based therapeutic products. It is important to emphasize that regulatory agencies have set up practices and procedures that are based on many years of evaluating pharmaceutically provided drugs. To consider cell-based therapies as single action drugs is inappropriate given the complexity of this technology. The regulatory agencies have been slowly reevaluating the criteria by which they allow clinical trials using cell-based therapies to proceed. This commentary focuses on a few key aspects of such considerations and provides suggestions for modifying the standard criteria.

Automated summary

The Commentary introduces cell-based therapy and discusses the potential criteria that the FDA might establish for the approval of clinical trials and eventual market approval of these cell-based therapeutic products. It emphasizes that considering cell-based therapies as single action drugs is inappropriate given their complexity. The regulatory agencies are slowly reevaluating the criteria for allowing clinical trials using cell-based therapies, and this Commentary offers suggestions for modifying the standard criteria.