Investigation^ cell therapy products-including those derived from stem and progenitor ceEs-hold great promise for addressing unmet medical needs but also present challenges related to product characterization, safety testing, and clinical trial design (Fig. 1). The U.S. Food and Drug Administration (FDA) adapts to the changing landscape of this evolving field by applying flexible regulatory standards that balance benefits and risks to those who take part in clinical trials. In this Focus, we describe the FDAs process for facilitating the development of safe and effective cell therapy products and highlight the importance of information sharing and transparency in the regulatory decision-making process.
展开▼
