The Food and Drug Administration (FDA) is announcing a public workshop entitled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The purpose of the public workshop is to convene a discussion on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the FDA. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act).
This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the Cures Act (Pub. L. 114-255). Section 3002 of Title III, Subtitle A, of the Cures Act directs FDA to develop patient-focused drug development guidance to address a number of areas, including how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidances.
In FDA's “Plan for Issuance of Patient-Focused Drug Development Guidance,” the FDA proposed issuing a guidance addressing this topic described in section 3002 during the second quarter of 2018. FDA recognizes that, like the other patient-focused drug development guidances described in the Plan, developing this draft guidance will also benefit from public input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders prior to FDA's drafting of the guidance. Accordingly, the FDA is scheduling this public workshop. After this public workshop, FDA will take into consideration the stakeholder input from the workshop and the public docket, and publish a draft guidance by the end of fiscal year 2018.
Members of the public may attend in person. More information is available via the Federal Register notice.