Pink Sheet is part of the Business 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


Patient Experience Data: Industry Seeks US FDA Clarity On Submission Pathway And Labeling

Executive Summary

Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.


Related Content

Patient Experience Data: US FDA’s Evidentiary Standards Should Reflect Intended Use
US FDA’s Patient Input Guidance Opens Door Wider To Social Media Data Collection
Benefit-Risk Frameworks May Be Coming To US FDA Advisory Committees
Gottlieb Showing Capitol Hill Skills With Funding Success
From Listening To Advising: The Maturation Of US FDA's Patient-Focused Drug Development Program
US FDA To Sponsors: Tell Us More About Your Drug Development Before We Meet
Patient Experience Data May Require Separate Label, Genentech Suggests


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