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

Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop; Request for Comments is organized by U.S. Food and Drug Administration (FDA) and will be held on Sep 10, 2018 at FDA Building 22, Silver Spring, Maryland, United States of America.

Conference Description :
The Food and Drug Administration (FDA) is holding a public workshop to discuss the current state and future directions for 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 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.

The premarket safety profile for topical drug products is supported by studies in animals and humans. In addition to adverse event information in clinical trials, human data for dermal toxicity are generated through dedicated studies to solicit potential irritancy, contact sensitization, phototoxicity, or photoallergenicity of the topical drug product. Although these safety studies on skin toxicity in humans have been typically included in the portfolio of clinical data submitted to support marketing applications, inclusion of their data in product labeling to help the prescriber is infrequent. FDA is holding this public workshop to obtain input on the complex scientific and regulatory issues relating to the conduct, interpretation, and utility of these studies. This input will aid FDA in planning future directions for the use of such studies.

Additional details will be posted as soon as they are available.