Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, Agency, or we) is announcing the following 1-day public workshop entitled ``Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation.'' The purpose of the public workshop is to provide a forum to discuss the current state and future directions of the collection of human data on the potential skin toxicity with the use of medications applied topically. The workshop will review current approaches to the collection of human data during the clinical development of topical drug products. The workshop will also address the impact of human skin toxicity studies on drug labeling and consider alternative approaches to providing information about skin toxicity.