Patient-Reported Outcomes To Be Available For ‘One-Stop Shopping’ In FDA Compendium
Public catalogue of assessment tools aims to foster collaborations and reduce regulatory uncertainties for drug developers trying to get clinical outcomes measurements into product labeling.
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'Pilot' document describes which measurements of patient experience have supported labeling claims, but FDA emphasizes they won't necessarily be the sole determinants.
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.
FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.