{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry, entitled \"Draft Guidance for Levonorgestrel.\" The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for a levonorgestrel intrauterine device.","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/2020/01/23/2020-01072.html","cfr_references":[],"citation":"85 FR 3924","comment_url":null,"comments_close_on":"2020-03-23","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by March 23, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[{"supporting_documents":[{"title":"PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0820"},{"title":"PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0818"},{"title":"PSG_212320 - Draft Guidance on Ferric Maltol re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0816"},{"title":"PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0805"},{"title":"PSG_206089 - Draft Guidance on Testosterone Undecanoate re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry;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"}],"agency_name":"FDA","documents":[{"comment_count":5,"comment_start_date":"2020-01-23","updated_at":"2023-02-28T13:49:32.866-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2007-D-0369-0481","allow_late_comments":null,"id":"FDA-2007-D-0369-0481","comment_end_date":"2020-03-24","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":111,"id":"FDA-2007-D-0369","title":"Industry Describing Product-Specific Bioequivalence Recommendations"}],"document_number":"2020-01072","effective_on":null,"end_page":3925,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/01/23/2020-01072.xml","html_url":"https://www.federalregister.gov/documents/2020/01/23/2020-01072/product-specific-guidance-for-levonorgestrel-intrauterine-device-revised-draft-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-01072?publication_date=2020-01-23","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-01-23/2020-01072/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":900,"last_updated":"2026-04-04 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-01-23/pdf/2020-01072.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-01072.pdf?1579700723","publication_date":"2020-01-23","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/01/23/2020-01072.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_count":5,"agency_id":"FDA","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","document_id":"FDA-2007-D-0369-0481","regulation_id_number":null,"title":"Industry Describing Product-Specific Bioequivalence Recommendations","checked_regulationsdotgov_at":"2023-02-28T18:49:32Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":3924,"subtype":null,"title":"Product-Specific Guidance for Levonorgestrel; Intrauterine Device; Revised Draft Guidance for Industry; Availability","toc_doc":"Levonorgestrel; Intrauterine Device","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}