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'Real Challenge' To Improve OTC Monograph Program Without User Fees – FDA

This article was originally published in The Tan Sheet

Executive Summary

FDA looks at the potential benefits and detriments from establishing user fees for the monograph program, opening a docket for comments in addition to conducting the public meeting, as it also considers comments to a docket launched in February 2014 on overhauling the OTC monograph process.

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