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FDA's new Office of Post-Marketing Drug Assessment to track Phase IV studies.

This article was originally published in The Tan Sheet

Executive Summary

FDA OFFICE OF POST-MARKETING DRUG RISK ASSESSMENT (OPDRA) will track Phase IV studies of approved NDAs, Center for Drug Evaluation & Research Deputy Director for Review Management Murray Lumpkin, MD, says in a Dec. 23 memo to FDA employees. NDAed OTC products will fall under the new office's purview; monographed OTCs will not be affected by the change.
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