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Rx-TO-OTC SWITCH LABELING STUDIES SHOULD BE SMALLER, PHASED TRIALS

This article was originally published in The Tan Sheet

Executive Summary

Rx-TO-OTC SWITCH LABELING STUDIES SHOULD BE SMALLER, PHASED TRIALS, as opposed to the larger studies FDA had initially endorsed, Office of OTC Drug Evaluation Director Michael Weintraub, MD, said Dec. 14 during a session on OTC drugs at the Food & Drug Law Institute's annual education conference. Weintraub noted that the agency is looking for "smaller studies which would be phased or graduated" to help determine appropriate labeling for OTC products.
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