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Acne drug guidance

This article was originally published in The Tan Sheet

Executive Summary

FDA is soliciting comments on a draft guidance for industry entitled, "Acne Vulgaris: Developing Drugs for Treatment," published in the Federal Register Sept. 19. The document provides "guidance on the development of drug products for the treatment of acne vulgaris other than nodulocystic acne" by helping applicants plan and design clinical studies, monitor the conduct of the trials, collect relevant data and perform appropriate analyses of the study data. For example, FDA suggests that drug trials be "randomized, blinded, multi-center trials with suitable comparator arms, which usually include a vehicle or placebo control," and "safety assessments, for short-term use, of both oral and topical acne drug products can include routine chemistry and hematology profiles." Comments are due Dec. 19...
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