Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Launches Compendium Of Clinical Outcome Assessments With Eye On Patients

This article was originally published in The Pink Sheet Daily

Executive Summary

'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...



Duke's McClellan: Changing Drug Development Policy From Outside FDA

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.

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.

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.

Topics

UsernamePublicRestriction

Register

MT142313

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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