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Stoughton vasoconstrictor test

Executive Summary

Is the current FDA standard for evaluation of generic versions of topical steroids approved after 1962, according to a guidance on ANDA bioequivalence study requirements issued by the agency in July. FDA is currently taking a closer look at the topical steroids and the vasoconstrictor methodology in light of two studies conducted by Richard Stoughton, MD, University of California-San Diego, showing significant differences between the potencies of brandname and generic products, and a third follow-up study by Duke University. "The Pink Sheet," July 17 issue (T&G-10) incorrectly stated that, according to FDA, Stoughton's second study results had not confirmed his first study.
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PS016153

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