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DPK guidance withdrawn

This article was originally published in The Tan Sheet

Executive Summary

FDA is withdrawing its draft guidance on dermatopharmacokinetics based on input from the public, agency advisory committees, FDA announces in May 17 Federal Register. Comments raised "substantial doubt" regarding the adequacy of DPK to assess bioequivalence of topical dermatological drugs because such products address a variety of diseases on different parts of the skin, not just stratum corneum, FDA explains. Reproducibility of the method between labs also was questioned. Agency plans to "explore the development of new methods and improvements in current methods" for documenting bioequivalence of topical dermatologicals...

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