{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled \"Draft Guidance on Risperidone.\" The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for risperidone injection.","action":"Notice.","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/2013/08/26/2013-20696.html","cfr_references":[],"citation":"78 FR 52777","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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 25, 2013.","disposition_notes":null,"docket_ids":["Docket No. FDA-2007-D-0369"],"dockets":[],"document_number":"2013-20696","effective_on":null,"end_page":52777,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2013/08/26/2013-20696.xml","html_url":"https://www.federalregister.gov/documents/2013/08/26/2013-20696/draft-guidance-for-industry-on-bioequivalence-recommendations-for-risperidone-injection-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2013-20696?publication_date=2013-08-26","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2013-08-26/2013-20696/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":949,"last_updated":"2026-10-25 12:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2013-08-26/pdf/2013-20696.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2013-20696.pdf?1377262139","publication_date":"2013-08-26","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2013/08/26/2013-20696.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":"2013-10-27T05:01:39Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52777,"subtype":null,"title":"Draft Guidance for Industry on Bioequivalence Recommendations for Risperidone Injection; Availability","toc_doc":"Bioequivalence Recommendations for Risperidone Injection","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":78}