Overview of the US Food and Drug Administration Regulatory Process

Abstract This chapter provides a brief historical review of the US Food and Drug Administration (FDA) and its organizational structure and discusses the regulation of regenerative medicine products, possible regulatory pathways for combination products, and relevant jurisdictional issues. Sources of information concerning FDA regulatory policies important to regenerative medicine product developers are also discussed. Suggestions are provided regarding how to engage the FDA effectively during the development of a novel regenerative medicine product.