{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry on generic doxycycline hyclate oral delayed-release tablets, entitled \"Product- Specific Guidance for Doxycycline Hyclate.\" The revised draft guidance, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new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 doxycycline hyclate oral delayed-release tablets.","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/2018/03/29/2018-06253.html","cfr_references":[],"citation":"83 FR 13488","comment_url":null,"comments_close_on":"2018-05-29","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by May 29, 2018 to ensure that the Agency considers your comments on the draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[{"supporting_documents":[{"title":"PSG_212725 - Draft Guidance on Entrectinib re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0820"},{"title":"PSG_212477 - Draft Guidance on Ledipasvir; Sofosbuvir re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0818"},{"title":"PSG_212320 - Draft Guidance on Ferric Maltol re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability","document_id":"FDA-2007-D-0369-0816"},{"title":"PSG_208612 - Draft Guidance on Ethinyl Estradiol; Levonorgestrel re Product-Specific Guidances; Draft and Revised Draft Guidances for Industry;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":0,"comment_start_date":"2018-03-29","updated_at":"2023-02-28T15:00:13.449-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2007-D-0369-0438","allow_late_comments":null,"id":"FDA-2007-D-0369-0438","comment_end_date":"2018-05-30","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":"2018-06253","effective_on":null,"end_page":13490,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/03/29/2018-06253.xml","html_url":"https://www.federalregister.gov/documents/2018/03/29/2018-06253/product-specific-guidance-for-doxycycline-hyclate-revised-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-06253?publication_date=2018-03-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-03-29/2018-06253/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":258,"last_updated":"2026-04-05 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-03-29/pdf/2018-06253.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-06253.pdf?1522241121","publication_date":"2018-03-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/03/29/2018-06253.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":0,"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-0369-0438","regulation_id_number":null,"title":"Industry Describing Product-Specific Bioequivalence Recommendations","checked_regulationsdotgov_at":"2023-02-28T20:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":13488,"subtype":null,"title":"Product-Specific Guidance for Doxycycline Hyclate; Revised Draft Guidance for Industry; Availability","toc_doc":"Product-Specific Guidance for Doxycycline Hyclate","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}