Patient-Reported Outcomes Data Earned Kybella A Claim For Emotional Impacts
Executive Summary
Labeling for the submental fat treatment includes a sentence about improvements in overall patient-reported satisfaction and self-perceived visual attributes based on questionnaire results from the Phase III trials.
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A listing of the Drug Review Profile series articles published in the Pink Sheet.
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Kythera met FDA's strict evidentiary requirements for clinician- and patient-reported outcomes assessments through close and frequent interactions with the agency and by addressing regulatory concerns about the instruments' design, validation and use in Phase III trials for the submental fat treatment.
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