{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled \"Bioequivalence Recommendations for Specific Products\" that explained the process that would be used to make product-specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.","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/2016/12/23/2016-30984.html","cfr_references":[],"citation":"81 FR 94394","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[],"document_number":"2016-30984","effective_on":null,"end_page":94396,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/12/23/2016-30984.xml","html_url":"https://www.federalregister.gov/documents/2016/12/23/2016-30984/product-specific-bioequivalence-recommendations-draft-and-revised-draft-guidances-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-30984?publication_date=2016-12-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-12-23/2016-30984/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":508,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-12-23/pdf/2016-30984.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-30984.pdf?1482414401","publication_date":"2016-12-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/12/23/2016-30984.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0820"},{"title":"PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0818"},{"title":"PSG_212320 - Draft Guidance on Ferric Maltol re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0816"},{"title":"PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0805"},{"title":"PSG_206089 - Draft Guidance on Testosterone Undecanoate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0802"},{"title":"PSG_022201 - Draft Guidance on Degarelix Acetate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0797"},{"title":"PSG_212862 - Draft Guidance on Pretomanid","document_id":"FDA-2007-D-0369-0544"},{"title":"PSG_211635 - Draft Guidance on Diazepam","document_id":"FDA-2007-D-0369-0540"},{"title":"PSG_208910 - Draft Guidance on Vancomycin Hydrochloride","document_id":"FDA-2007-D-0369-0537"},{"title":"PSG_207071 - Draft Guidance on Azelaic Acid","document_id":"FDA-2007-D-0369-0533"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2007-D-0369","supporting_documents_count":111,"docket_id":"FDA-2007-D-0369","regulation_id_number":null,"title":"Industry Describing Product-Specific Bioequivalence Recommendations","checked_regulationsdotgov_at":"2017-02-22T05:00:55Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":94394,"subtype":null,"title":"Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability","toc_doc":"Product-Specific Bioequivalence Recommendations","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}