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FDA Rx-to-OTC switch draft guidelines clarify OTC division responsibilities.

This article was originally published in The Tan Sheet

Executive Summary

OTC DIVISION OVERSIGHT OF ACTUAL USE AND LABEL COMPREHENSION STUDIES is laid out in FDA draft procedural guidelines for OTC NDA and Rx-to-OTC switch processes. "A reviewer from the [Division of OTC Drug Products] should usually be responsible for studies related to the OTC situation (identification of the OTC population, drug actual use studies to determine safety of the use of the product in an OTC setting [and] labeling comprehension studies)," the draft guidelines specify.
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