ABSTRACT
This guidance is intended to help applicants decide whether they should test for photoirritation and assess the potential of their drug product to enhance ultraviolet (UV)-associated skin carcinogenesis, something the new applicants will find the U.S. Food and Drug Administration (FDA) is often keen to know. The guidance describes a consistent, science-based approach for photosafety evaluation of topically and systemically administered drug products. Basic concepts of photobiology and phototesting are described, along with a process that can be used to make testing decisions or communicate risks.
