{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on the submission of bioequivalence data to require an abbreviated new drug application (ANDA) applicant to submit data from all bioequivalence (BE) studies the applicant conducts on a drug product formulation submitted for approval. In the past, ANDA applicants have submitted BE studies demonstrating that a generic product meets bioequivalence criteria in order for FDA to approve the ANDA, but have not typically submitted additional BE studies conducted on the same drug product formulation, such as studies that do not show that the product meets these criteria. FDA is amending the regulation because we now believe that data from additional BE studies may be important in our determination of whether the proposed formulation is bioequivalent to the reference listed drug (RLD), and are relevant to our evaluation of ANDAs in general. In addition, such data will increase our understanding of how changes in components, composition, and methods of manufacture may affect product formulation performance.","action":"Final rule.","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/2009/01/16/E9-884.html","cfr_references":[{"chapter":null,"citation_url":null,"part":314,"title":21},{"chapter":null,"citation_url":null,"part":320,"title":21}],"citation":"74 FR 2849","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The rule is effective July 15, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2003-N-0209"],"dockets":[],"document_number":"E9-884","effective_on":"2009-07-15","end_page":2862,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/01/16/E9-884.xml","html_url":"https://www.federalregister.gov/documents/2009/01/16/E9-884/requirements-for-submission-of-bioequivalence-data-final-rule","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-884?publication_date=2009-01-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-01-16/E9-884/mods.xml","not_received_for_publication":null,"page_length":14,"page_views":{"count":5057,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-01-16/pdf/E9-884.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-01-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/01/16/E9-884.txt","regulation_id_number_info":{"0910-AC23":{"issue":"200810","html_url":"https://www.federalregister.gov/regulations/0910-AC23/requirements-for-submission-of-in-vivo-bioequivalence-data","title":"Requirements for Submission of In Vivo Bioequivalence Data","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200810&RIN=0910-AC23&operation=OPERATION_EXPORT_XML","priority_category":"Substantive, Nonsignificant"}},"regulation_id_numbers":["0910-AC23"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Background Information","document_id":"FDA-2003-N-0209-0007"},{"title":"Background Information","document_id":"FDA-2003-N-0209-0006"},{"title":"Background Information","document_id":"FDA-2003-N-0209-0005"},{"title":"Background Information","document_id":"FDA-2003-N-0209-0004"},{"title":"Background Information","document_id":"FDA-2003-N-0209-0003"},{"title":"Background Information","document_id":"FDA-2003-N-0209-0002"}],"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2003-N-0209","supporting_documents_count":6,"docket_id":"FDA-2003-N-0209","document_id":"FDA-2003-N-0209-0008","regulation_id_number":null,"title":"Requirements for Submission of In Vivo Bioequivalence Data; Proposed Rule","checked_regulationsdotgov_at":"2025-02-12T16:56:17Z"},"regulations_dot_gov_url":null,"significant":false,"signing_date":null,"start_page":2849,"subtype":null,"title":"Requirements for Submission of Bioequivalence Data; Final Rule","toc_doc":"Requirements for Submission of Bioequivalence Data","toc_subject":null,"topics":["Administrative practice and procedure","Confidential business information","Drugs","Reporting and recordkeeping requirements"],"type":"Rule","volume":74}