The Food and Drug Administration's Role in Dermatologic Drug Development

The mission of the Food and Drug Administration (FDA) is to ensure the safety and effectiveness of dermatologic drugs, as authorized by the Federal Food, Drug, and Cosmetic Act (FD&CA). In this article, we discuss how the FDA's policies and practices have continued to evolve to incorporate scientific advances and to facilitate approval for dermatologic drugs in a timely manner for a broad spectrum of patients. We provide several examples to highlight areas where the Division of Dermatology and Dentistry found common ground with stakeholders to increase the therapeutic options for dermatologic patients, while still maintaining regulatory standards required for approval.