Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data Guidance for Industry and Other Stakeholders
This guidance provides information on how a person can submit a proposed draft guidance 16 relating to patient experience data for consideration by FDA. This guidance is intended to assist 17 stakeholders seeking to develop and submit such proposed draft guidance to the Agency. In 18 addition, FDA recognizes that stakeholders may have other information on patient experience 19 data that they would like to share with FDA outside of the guidance process and thus provides 20 information on other ways stakeholders can advance drug development by sharing patient 21 experience data. Section 3002(c)(5) of the 21st Century Cures Act (Cures Act) directs FDA to issue guidance on how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the Agency