E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability
Published Date: 2/6/2026
Notice
Summary
The FDA just dropped a draft guide to help drug makers understand how to include patient preferences in their studies. This new guidance will shape how drugs get developed and approved by making sure patients’ voices count. If you’re in the drug biz, get your comments in by April 7, 2026, or risk missing out on influencing the final rules!
Analyzed Economic Effects
4 provisions identified: 3 benefits, 1 costs, 0 mixed.
Draft guidance on patient preferences
The FDA released a draft guidance called “E22 General Considerations for Patient Preference Studies” that explains general principles for the use, design, conduct, analysis, and submission of patient preference studies to inform drug development, regulatory submissions, drug approvals, and maintenance of approvals. The ICH Assembly endorsed the draft in November 2025 and the FDA is accepting public comments through April 7, 2026.
Public comment deadline April 7, 2026
Stakeholders who want the FDA to consider their views must submit comments on the draft guidance by April 7, 2026 to ensure the Agency considers those comments before it begins work on the final guidance. Comments can be submitted electronically at https://www.regulations.gov (Docket No. FDA-2026-D-0207) or as written/paper submissions following FDA instructions.
No Paperwork Reduction Act burden
The FDA tentatively concludes that the draft guidance contains no collection of information, so clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. This means the draft guidance, as written, does not create new information-collection paperwork obligations subject to OMB review.
Guidance is nonbinding and flexible
The FDA states that this draft guidance does not establish legally enforceable responsibilities and represents the Agency's current thinking; sponsors may use alternative approaches if they satisfy applicable statutes and regulations. The final guidance will be reformatted to FDA style and the Agency will consider comments (including on costs or cost savings) as it develops the final version.
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