{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Vulvovaginal Candidiasis: Developing Drugs for Treatment.\" The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of uncomplicated vulvovaginal candidiasis (VVC).","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/2016/07/01/2016-15661.html","cfr_references":[],"citation":"81 FR 43212","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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 29, 2016.","disposition_notes":null,"docket_ids":["Docket No. FDA-2016-D-1662"],"dockets":[],"document_number":"2016-15661","effective_on":null,"end_page":43214,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/07/01/2016-15661.xml","html_url":"https://www.federalregister.gov/documents/2016/07/01/2016-15661/vulvovaginal-candidiasis-developing-drugs-for-treatment-draft-guidance-for-industry-availability","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-15661?publication_date=2016-07-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-07-01/2016-15661/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":245,"last_updated":"2026-04-24 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15661.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-15661.pdf?1467290952","publication_date":"2016-07-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/07/01/2016-15661.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2016-D-1662","supporting_documents_count":0,"docket_id":"FDA-2016-D-1662","regulation_id_number":null,"title":"Candidiasis: Developing Drugs for Treatment","checked_regulationsdotgov_at":"2016-09-30T05:00:33Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":43212,"subtype":null,"title":"Vulvovaginal Candidiasis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability","toc_doc":"Vulvovaginal Candidiasis: Developing Drugs for Treatment","toc_subject":"Guidance for Industry:","topics":[],"type":"Notice","volume":81}