{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"Statistical Approaches to Establishing Bioequivalence.\" This guidance provides recommendations to sponsors and applicants planning to use equivalence criteria in analyzing bioequivalence (BE) studies for investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and amendments and supplements to these applications. The guidance discusses statistical approaches for BE comparisons and focuses on how to use these approaches both generally and in specific situations. This guidance finalizes the draft guidance of the same title issued on December 5, 2022, and replaces the guidance of the same title issued on February 2, 2001.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2026/05/29/2026-10705.html","cfr_references":[],"citation":"91 FR 32056","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on May 29, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2001-D-0197"],"dockets":[],"document_number":"2026-10705","effective_on":null,"end_page":32057,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/29/2026-10705.xml","html_url":"https://www.federalregister.gov/documents/2026/05/29/2026-10705/statistical-approaches-to-establishing-bioequivalence-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-10705?publication_date=2026-05-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-29/2026-10705/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":396,"last_updated":"2026-06-27 12:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-29/pdf/2026-10705.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-10705.pdf?1779972316","publication_date":"2026-05-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/29/2026-10705.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2026-05-29T08:56:21Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":32056,"subtype":null,"title":"Statistical Approaches To Establishing Bioequivalence; Guidance for Industry; Availability","toc_doc":"Statistical Approaches to Establishing Bioequivalence","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}