Section 3002(c)(5) of the 21st Century Cures Act directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency.
To inform the development of this draft guidance, FDA conducted a public workshop in March 2018. In addition to providing input at the public workshop, stakeholders were also invited to submit comments through the public docket.
In December 2018, FDA issued draft guidance that is intended to assist stakeholders seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA. FDA recognizes that stakeholders may have other information on patient experience data that they would like to share with FDA outside of the guidance process and thus provides information in this draft guidance on other ways stakeholders can advance drug development by sharing patient experience data.
For more information, please see FDA Draft Guidance on Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.
If you have any questions, please contact FDA’s CDER Patient-Focused Drug Development Program Staff by emailing firstname.lastname@example.org.