Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future.

Abstract

Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of available therapies within regenerative dermatology, outlining the pathways for approval. Articles on regenerative dermatology in PubMed and guidelines issued by the United States Food and Drug Administration (FDA) were reviewed with emphasis on those publish