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FDA ANALGESIC SUBCMTE. DECLINES TO ENDORSE SPECIFIC CLINICAL PAIN MODELS

This article was originally published in The Tan Sheet

Executive Summary

FDA ANALGESIC SUBCMTE. DECLINES TO ENDORSE SPECIFIC CLINICAL PAIN MODELS as general assays for establishing efficacy of an OTC analgesic due to concerns that such an approach would impede the future development of better clinical models. Discussion by the FDA subcommittee at its Sept. 9 meeting focusing on appropriate "primary" and "secondary" pain models ended when several members and outside experts expressed reservations about recommending one or two specific pain models as the basis for an Rx-to-OTC switch application.
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