Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Patient-Reported Outcomes To Be Available For ‘One-Stop Shopping’ In FDA Compendium

Executive Summary

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.

You may also be interested in...



FDA Launches Compendium Of Clinical Outcome Assessments With Eye On Patients

'Pilot' document describes which measurements of patient experience have supported labeling claims, but FDA emphasizes they won't necessarily be the sole determinants.

Kybella Approval Shows How To Work With FDA On Clinical Outcome Assessments

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.

PDUFA VI: Price Tag For Patient Experience Data Validation May Go Up

FDA wants to advance PRO projects through the user fee reauthorization, but ironically is having difficulty quantifying how much support it might need.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS056766

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel