E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability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Draft guidance on patient preferences
The FDA released a draft guidance called “E22 General Considerations for Patient Preference Studies” that explains general principles for the use, design, conduct, analysis, and submission of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Stakeholders who want the FDA to consider their views must submit comments on the draft guidance by April 7, 2026 to ensure the Agency considers those comments before it begins work on the final guidance.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The FDA tentatively concludes that the draft guidance contains no collection of information, so clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. This means the draft guidance, as written, does not create new information-collection paperwork obligations subject to OMB review.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The FDA states that this draft guidance does not establish legally enforceable responsibilities and represents the Agency's current thinking; sponsors may use alternative approaches if they satisfy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.
Your PRIA Score
Personalized for You
How does this regulation affect your finances?
Sign up for a PRIA Policy Scan to see your personalized alignment score for this federal register document and every other regulation we track. We analyze your financial profile against policy provisions to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-06379 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; KRESLADI (marnetegragene autotemcel)
The FDA just gave Rocket Pharmaceuticals a special priority review voucher for their rare pediatric disease treatment, KRESLADI, approved on March 26, 2026. This voucher speeds up future FDA reviews, helping get important medicines to kids with rare diseases faster. It’s a big win for patients, the company, and anyone cheering for quicker cures!
2026-06314 — Determination That INAPSINE (Droperidol) Injection, 2.5 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The FDA has decided that INAPSINE (droperidol) injection wasn’t taken off the market because of safety or effectiveness problems. This means generic versions can keep being approved and sold as long as they follow the rules. Patients and healthcare providers can keep trusting this medicine without worry, and drug makers can continue their work without delays or extra costs.
2026-06294 — Consideration of Acceptable Market Name Change for Certain Rockfish (Sebastes spp.); Request for Information
The FDA wants to hear from fishermen, seafood sellers, and fish lovers about possibly changing the official market names for certain rockfish species. This update aims to make fish labels clearer and safer for everyone, with comments open until May 1, 2026. If the name changes happen, it could affect how these fish are sold and marketed, so your input matters!
2026-06316 — Issuance of Priority Review Voucher; Rare Pediatric Disease Product; YUVIWEL (navepegritide)
The FDA just gave Ascendis Pharma a special priority review voucher for their rare pediatric disease drug, YUVIWEL, which helps kids with achondroplasia grow taller. This voucher speeds up future drug reviews and can be a valuable asset, saving time and potentially money. Approved on February 27, 2026, this move highlights the FDA’s commitment to fast-tracking treatments for rare childhood conditions.
2026-06187 — Notice of Decision on a Hearing Request Regarding a Proposal To Refuse To Approve a New Drug Application for TRADIPITANT Capsules
The FDA has decided not to approve Vanda Pharmaceuticals’ new drug, TRADIPITANT capsules, meant to treat symptoms of gastroparesis. Vanda asked for a hearing to challenge this, but the FDA denied it. This means patients and doctors will have to wait longer for this treatment, and Vanda faces delays and extra costs as they figure out their next move.
2026-05913 — Elite Laboratories, Inc., et al.; Withdrawal of Approval of 72 Abbreviated New Drug Applications; Correction
The FDA fixed a mistake about pulling approvals for 72 generic drug applications. One drug, a valproic acid capsule from Upsher-Smith Laboratories, won’t lose its approval because the company asked to keep it. This means the drug stays available, and the change took effect before October 23, 2025.
Previous / Next Documents
Previous: 2026-02323 — Submission for Office of Management and Budget Review; ACF Performance Progress Report, ACF-OGM-SF-PPR-B
The Administration for Children and Families wants to keep using their Performance Progress Report form for three more years but with fewer questions to make it easier for grantees to fill out. This change affects state, tribal, and local groups who get grants and helps make sure projects stay on track without extra hassle. Comments on these updates are open until March 9, 2026.
Next: 2026-02327 — Combined Notice of Filings #1
The Federal Energy Regulatory Commission got a bunch of filings from energy companies like Arizona Public Service and Duke Energy about changes in their status, refunds, and new agreements. These updates could affect electric rates and services soon, with important comment deadlines mostly in February 2026. If you’re involved in energy or just curious, now’s the time to check out these changes and speak up before the deadlines!
Take It Personal
Get Your Personalized Policy View
Start a Free Government Policy Watch to see how policy affects your household, then upgrade to PRIA Full Coverage for year-round monitoring.
Already have an account? Sign in