FDA Finds Creative Labeling Solution For Egrifta Patient-Reported Outcomes Data
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA faces a challenge when it receives results from a patient-reported outcomes tool that it does not think is properly validated, but was designed in consultation with the agency.
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The approval of Theratechnologies’ HIV lipodystrophy treatment Egrifta (tesamorelin) shows how much FDA can be swayed by unmet need, even where the product has limited efficacy in a narrow population and substantial potential for off-label use.