FDA Draft Guidance on Patient Preference Studies

The Food and Drug Administration (FDA) has issued a draft guidance document titled "E22 General Considerations for Patient Preference Studies." This guidance, developed in collaboration with the International Council for Harmonisation (ICH), aims to provide principles for the design, conduct, analysis, and submission of patient preference studies that can inform drug development, regulatory submissions, and approvals.

This document is currently open for public comment, with a deadline of April 7, 2026. Interested parties, including drug manufacturers and pharmaceutical companies, are encouraged to submit their feedback to the FDA via the provided online portal or by mail to ensure their input is considered before the final guidance is developed. The docket number for this consultation is FDA-2026-D-0207.