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

This article was originally published in The Rose Sheet

Executive Summary

FDA is weighing the potential benefits of, and drawbacks to, establishing user fees to support its OTC drug monograph program, opening a docket for comments and conducting a June 10 public meeting on the subject. Industry seems far from on board at present, and FDA also acknowledges that there could be downsides to a user fee program in addition to potential benefits for companies and consumers.

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