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Obesity Therapy Gap Or Regulatory Gap? REMS Not The Answer For Belviq Or GW Group

This article was originally published in RPM Report

Executive Summary

A common theme in FDA’s review of three different weight loss drugs has been discussion of whether a Risk Evaluation & Mitigation Strategy program can help assure appropriate use of the therapies. FDA clearly thinks the answer is “no.” But that doesn’t end the discussion of what tools can be used to help curb off-label use.

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