Regenerative Medicine Advanced Therapies: Efforts to Facilitate Product Development and Approval at the Center for Biologics Evaluation and Research
FDA, United States
Regenerative medicine advanced therapies include certain cell therapies, therapeutic tissue engineering products, human cell and tissue products, and combination products, including genetically modified cellular therapies and gene therapies that produce durable effects. Challenges in the development of these products range from establishing a consistent manufacturing process to demonstrating efficacy in clinical trials. This session will address the regulatory framework for regenerative medicine products, Regenerative Medicine Advanced Therapy designation, and will also suggest potential pathways sponsors can take to address issues related to manufacturing and clinical trial design.
Learning Objective : Describe the regulatory framework for regenerative medicine products; Identify potential pathways sponsor can take for issues related to manufacturing and clinical trial design.