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In Brief: FDA drug approval application form

This article was originally published in The Tan Sheet

Executive Summary

FDA drug approval application form: FDA announces availability of revised form FDA 356h for use by applicants submitting all NDAs and ANDA/AADAs in the July 9 Federal Register. The revised form replaces the FDA 356h for NDAs, ANDAs/AADAs revised in October 1993. FDA says it "believes that a harmonized application format will allow companies to provide higher quality submissions, reduce preparation time, expedite review by FDA and easily adapt to electronic submissions when that becomes possible and practical." Applicants can use the form now; its use will be required beginning Jan. 8...
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