Pink Sheet is part of the Informa Intelligence Division 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


From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program

Executive Summary

With the disease-area meetings required under PDUFA V now behind it, FDA is turning its attention to guiding sponsors and advocacy groups on how to systematically collect patient experience data for use in drug development and regulatory decision-making. At least two guidance documents and a new data repository are on tap for 2018.


Related Content

Clinical Trial Reform Is A Focus For CDER's 2019 Guidance Agenda
US FDA Expands Patient Input To New Area: Orphan Grant Applications
US FDA Mulling Core Criteria For Patient-Reported Outcomes
Patient-Focused Guidance Writing: FDA Aiming For 'Sweet Spot' In Advice
FDA Ends Regularly Scheduled Patient-Focused Drug Development Meetings
Patient Experience Data May Require Separate Label, Genentech Suggests
FDA's Gottlieb Pushing 'Seamless' Clinical Trials For Faster Development
FDA's 21st Century Cures Plan Gives Patient-Focused Drug Development A Boost
Will Patient-Reported Data Require New Drug Labeling Framework?
Duchenne Muscular Dystrophy: FDA Supports Broader Outcome Measures, Biomarkers


Related Companies




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