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FDA Targets Acetaminophen Safety Evaluation In Plan To Mine OTC Use Data

This article was originally published in The Pink Sheet Daily

Executive Summary

An RFP to provide FDA with direct access to data on consumers’ OTC use identifies the public health impact of potential changes in dosing information on acetaminophen product labels as one reason for the planned data evaluation. Access to the data also will increase FDA’s ability to perform regulatory impact studies, particularly to assess the impact of Rx-to-OTC switches.

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