Food and drug administration approval process for dermatology drugs in the United States

Abstract

Aim: The purpose of this review is to elucidate the steps involved in the FDA’s approval of new dermatology drugs.

Methods: To help illustrate the process of drug approval, we use examples from the recent approval of dupilumab (REGN668; Regeneron Pharmaceuticals).

Results: In general, new dermatology drugs must undergo pre-clinical studies on non-human subjects and three phases of clinical trials in humans before undergoing review by the Food and Drug Administration (FDA). This review process involves an interdisciplinary team of scientists that determines if the drug should be brought to market based on its efficacy, risk-to-benefit ratio, and ability to be labeled. The team that specifically reviews dermatology drugs within the Center for Drug Evaluation and Research (CDER) at the FDA is the Division of Dermatologic and Dental Drug Products.

Conclusions: The drug development process is enhanced by clinician input during all stages of development.

Keywords:

• Food and Drug Administration
• dermatology
• drugs
• treatments
• therapies
• approval
• process

Disclosure statement

Shawn Kwatra is on the advisory board at Menlo Therapeutics.

The content in this manuscript has not been published or submitted for publication elsewhere. All authors have contributed significantly, and are in agreement with the content of the manuscript.