{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"COVID-19: Developing Drugs and Biological Products for Treatment or Prevention.\" The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. This guidance describes FDA's current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations. This guidance supersedes the guidance of the same name initially issued on May 19, 2020, and reissued on February 22, 2021.","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/2023/11/24/2023-25952.html","cfr_references":[],"citation":"88 FR 82382","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on November 24, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2020-D-1370"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-11-24","updated_at":"2023-11-24T09:57:28.902-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1370-0027","allow_late_comments":null,"id":"FDA-2020-D-1370-0027","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-1370","title":"COVID-19 - Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability "}],"document_number":"2023-25952","effective_on":null,"end_page":82383,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/24/2023-25952.xml","html_url":"https://www.federalregister.gov/documents/2023/11/24/2023-25952/covid-19-developing-drugs-and-biological-products-for-treatment-or-prevention-guidance-for-industry","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-25952?publication_date=2023-11-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-24/2023-25952/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1125,"last_updated":"2026-07-27 00:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-24/pdf/2023-25952.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-25952.pdf?1700660841","publication_date":"2023-11-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/24/2023-25952.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-2020-D-1370","supporting_documents_count":0,"docket_id":"FDA-2020-D-1370","document_id":"FDA-2020-D-1370-0027","regulation_id_number":null,"title":"COVID-19 - Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability ","checked_regulationsdotgov_at":"2023-11-25T17:00:08Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":82382,"subtype":null,"title":"COVID-19: Developing Drugs and Biological Products for Treatment or Prevention; Guidance for Industry; Availability","toc_doc":"COVID19: Developing Drugs and Biological Products for Treatment or Prevention","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}