FDA Launches Compendium Of Clinical Outcome Assessments With Eye On Patients
This article was originally published in The Pink Sheet Daily
'Pilot' document describes which measurements of patient experience have supported labeling claims, but FDA emphasizes they won't necessarily be the sole determinants.
You may also be interested in...
In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.
FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.
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.