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

21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’

Executive Summary

Lame-duck passage is goal of changes to reform legislation, which now includes highly targeted funding for FDA.

You may also be interested in...



US FDA Should Explain How It Uses Patient Experience Data In Drug Approvals – Report

Review documents do not always reflect whether PED was considered as part of an application, and stakeholders cannot easily determine how such data are used in the agency’s regulatory decision-making, an independent consultant review found.

'Patient Experience Data' Section Added To US FDA Drug Reviews

Genentech's hemophilia A treatment Hemlibra is among first products to include new dedicated section on patient experience data in its review documents as FDA begins implementing 21st Century Cures Act provision.

Not Quite FDARA Add-Ons: Right-To-Try, Patient Experience, Opioid Measures Also Clear US Senate

Senate passage of the FDA user fee package without amendments was enabled by unanimous consent votes on controversial right-to-try legislation that is toned down from its initial version, as well as two other bills.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS119584

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