{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.\" This draft guidance provides nonclinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research (CDER) at FDA for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection.","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/2018/06/14/2018-12761.html","cfr_references":[],"citation":"83 FR 27782","comment_url":null,"comments_close_on":"2018-08-13","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by August 13, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2018-D-1918"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2018-06-14","updated_at":"2023-03-01T01:41:59.845-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2018-D-1918-0001","allow_late_comments":null,"id":"FDA-2018-D-1918-0001","comment_end_date":"2018-08-14","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2018-D-1918","title":"Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry"}],"document_number":"2018-12761","effective_on":null,"end_page":27783,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/14/2018-12761.xml","html_url":"https://www.federalregister.gov/documents/2018/06/14/2018-12761/human-immunodeficiency-virus-1-infection-developing-systemic-drug-products-for-pre-exposure","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-12761?publication_date=2018-06-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-14/2018-12761/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":267,"last_updated":"2026-10-25 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-14/pdf/2018-12761.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-12761.pdf?1528893924","publication_date":"2018-06-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/14/2018-12761.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-D-1918","supporting_documents_count":0,"docket_id":"FDA-2018-D-1918","document_id":"FDA-2018-D-1918-0001","regulation_id_number":null,"title":"Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry","checked_regulationsdotgov_at":"2023-03-01T06:41:59Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":27782,"subtype":null,"title":"Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis; Draft Guidance for Industry; Availability","toc_doc":"Human Immunodeficiency Virus1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":83}