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OTC NDA review guidelines to be out in six months -- FDA's Lumpkin.

This article was originally published in The Tan Sheet

Executive Summary

FDA GUIDELINES ON OTC NDA REVIEW PROCESS are targeted for release within the next six months, FDA Center for Drug Evaluation & Research Deputy Director for Review Management Murray Lumpkin, MD, reported at the Nonprescription Drug Manufacturers Association's annual R&D conference on Sept. 13. Lumpkin noted that a "stretch goal" for the completion of such a policy is by the end of this calendar year. The FDAer commented that NDMA's input on review process issues has been "very helpful."
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