{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled \"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.\" This revised draft supersedes the draft guidance entitled \"Bioequivalence Studies With Pharmacokinetic Endpoints for Drug Products Submitted Under an ANDA,\" which was announced in the Federal Register on December 5, 2013. This revised draft guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.","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/2021/08/23/2021-18073.html","cfr_references":[],"citation":"86 FR 47117","comment_url":null,"comments_close_on":"2021-10-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by October 22, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1464"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2021-08-23","updated_at":"2023-02-28T22:28:08.316-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2013-D-1464-0016","allow_late_comments":null,"id":"FDA-2013-D-1464-0016","comment_end_date":"2021-10-23","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2013-D-1464","title":"Draft Guidance for Industry on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA; Availability"}],"document_number":"2021-18073","effective_on":null,"end_page":47118,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/08/23/2021-18073.xml","html_url":"https://www.federalregister.gov/documents/2021/08/23/2021-18073/bioequivalence-studies-with-pharmacokinetic-endpoints-for-drugs-submitted-under-an-abbreviated-new","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-18073?publication_date=2021-08-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-08-23/2021-18073/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":2019,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-08-23/pdf/2021-18073.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-18073.pdf?1629463553","publication_date":"2021-08-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/08/23/2021-18073.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-1464","supporting_documents_count":0,"docket_id":"FDA-2013-D-1464","document_id":"FDA-2013-D-1464-0016","regulation_id_number":null,"title":"Draft Guidance for Industry on Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted under an ANDA; Availability","checked_regulationsdotgov_at":"2023-03-01T03:28:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47117,"subtype":null,"title":"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Draft Guidance for Industry; Availability","toc_doc":"Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted under an Abbreviated New Drug Application","toc_subject":"Draft Guidance for Industry; Availability:\n","topics":[],"type":"Notice","volume":86}