{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Patient- Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making.\" This draft guidance (Guidance 4) is the fourth in a series of four methodological patient- focused drug development (PFDD) guidance documents that describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used for medical product development and regulatory decision-making.","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/2023/04/06/2023-07243.html","cfr_references":[],"citation":"88 FR 20530","comment_url":null,"comments_close_on":"2023-07-05","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by July 5, 2023 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2023-D-0026"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":10,"comment_start_date":"2023-04-06","updated_at":"2023-07-19T01:01:19.370-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-0026-0001","allow_late_comments":null,"id":"FDA-2023-D-0026-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-D-0026","title":"Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability"},{"supporting_documents":[{"title":"Guidance: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements","document_id":"FDA_FRDOC_0001-12016"},{"title":"Meetings: Patient-Focused Drug Development for Long COVID","document_id":"FDA_FRDOC_0001-12015"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-04-06","updated_at":"2023-04-06T09:57:08.184-04:00","comment_url":"https://www.regulations.gov/commenton/FDA_FRDOC_0001-12120","allow_late_comments":null,"id":"FDA_FRDOC_0001-12120","comment_end_date":"2023-07-06","regulations_dot_gov_open_for_comment":true}],"supporting_documents_count":0,"id":"FDA_FRDOC_0001","title":"Recently Posted FDA Rules and Notices."}],"document_number":"2023-07243","effective_on":null,"end_page":20531,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/04/06/2023-07243.xml","html_url":"https://www.federalregister.gov/documents/2023/04/06/2023-07243/patient-focused-drug-development-incorporating-clinical-outcome-assessments-into-endpoints-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-07243?publication_date=2023-04-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-04-06/2023-07243/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1780,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-06/pdf/2023-07243.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07243.pdf?1680698734","publication_date":"2023-04-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/04/06/2023-07243.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":10,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-0026","supporting_documents_count":0,"docket_id":"FDA-2023-D-0026","document_id":"FDA-2023-D-0026-0001","regulation_id_number":null,"title":"Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2023-07-20T01:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":20530,"subtype":null,"title":"Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","toc_doc":"Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making","toc_subject":"Guidance","topics":[],"type":"Notice","volume":88}