News & Events > Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

News & Events > Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

FDA Public Workshop on Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data

On March 19th, FDA is conducting a public workshop to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by the FDA may submit such proposed draft guidance to the Agency. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act. FDA is seeking information and comments from a broad range of stakeholders, including patients, patient advocates, academic and medical researchers, expert practitioners, drug developers and other interested persons. To learn more, please visit:
https://www.fda.gov/Drugs/NewsEvents/ucm582081.htm .