federal_register: 2026-02324

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2026-02324 E22 General Considerations for Patient Preference Studies; International Council for Harmonisation; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "E22 General Considerations for Patient Preference Studies." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).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. 2026-02-06 2026 2 https://www.federalregister.gov/documents/2026/02/06/2026-02324/e22-general-considerations-for-patient-preference-studies-international-council-for-harmonisation https://www.govinfo.gov/content/pkg/FR-2026-02-06/pdf/2026-02324.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "E22 General Considerations for Patient Preference Studies." The draft guidance was prepared under the auspices of the...

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