The Food and Drug Administration (FDA) is soliciting public comments for the docket titled “Patient-Focused Drug Development: Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data.” The FDA seeks public input on how a person seeking to develop and submit proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidance to the FDA. These comments will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act).
These comments are 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drug development guidance to address a number of areas, including how a person seeking to develop and submit a proposed draft guidance relating to patient experience data for consideration by FDA may submit such proposed draft guidances.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 FDA recognizes that, like the other patient-focused drug development guidances described in the Plan, developing this draft guidance will also benefit from public input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and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 seeks public comments; after the comment deadline, FDA will take into consideration the stakeholder input and publish a draft guidance by the end of fiscal year 2018.