FDA Draft Guidance on Patient Preference Studies

FDA Newly Added Guidance

Published April 7th, 2026

Detected February 6th, 2026

Summary

The FDA has released draft guidance on general considerations for patient preference studies, developed under the International Council for Harmonisation (ICH). The agency is accepting public comments on this draft guidance until April 7, 2026.

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What changed

The Food and Drug Administration (FDA) has issued a draft guidance document titled "E22 General Considerations for Patient Preference Studies."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.

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Submit Comments by

04/07/2026

Submit Comments Online Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2026-D-0207

Docket Number: FDA-2026-D-0207 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “E22 General Considerations for Patient Preference Studies.” The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). When finalized, this guidance will provide general principles for the use, design, conduct, analysis, and submission of patient preference studies (PPS) aimed at informing drug development, regulatory submission and evaluation, drug approvals, and maintenance of such approvals.