Topical drugs quantitative formulation data disclosure sought by Perrigo.
This article was originally published in The Tan Sheet
Executive Summary
TOPICAL DRUGS QUANTITATIVE FORMULATION INFO DISCLOSURE in FDA's Inactive Ingredient Guide sought by Perrigo for all topical routes as a way to eliminate unnecessary human testing, the private labeler says in Aug. 13 comments on FDA's draft guidance for topical dermatological products. FDA issued the draft, "Topical Dermatological Drug Product NDAs and ANDAs -- In Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated Studies," June 18 ("The Tan Sheet" June 29, p. 25).