{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry, FDA staff, and other stakeholders entitled \"Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.\" This guidance (Guidance 2) is the second in a series of four methodological guidance documents that FDA committed to develop to describe how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision making. This guidance finalizes the draft guidance of the same title issued on October 1, 2019.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN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/2022/02/28/2022-04152.html","cfr_references":[],"citation":"87 FR 11077","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on February 28, 2022.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-4247"],"dockets":[],"document_number":"2022-04152","effective_on":null,"end_page":11079,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2022/02/28/2022-04152.xml","html_url":"https://www.federalregister.gov/documents/2022/02/28/2022-04152/patient-focused-drug-development-methods-to-identify-what-is-important-to-patients-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2022-04152?publication_date=2022-02-28","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2022-02-28/2022-04152/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":929,"last_updated":"2026-10-22 14:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2022-02-28/pdf/2022-04152.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2022-04152.pdf?1645796729","publication_date":"2022-02-28","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2022/02/28/2022-04152.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Patient-Focused Drug Development: Methods to Identify What Is Important to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders","document_id":"FDA-2019-D-4247-0088"},{"title":"Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","document_id":"FDA-2019-D-4247-0087"},{"title":"Patient-Focused Drug Development: Methods to Identify What Is\nImportant to Patients Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; DRAFT GUIDANCE","document_id":"FDA-2019-D-4247-0002"},{"title":"Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug\nAdministration Staff, and Other Stakeholders; Availability","document_id":"FDA-2019-D-4247-0001"}],"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-2019-D-4247","supporting_documents_count":4,"docket_id":"FDA-2019-D-4247","document_id":"FDA-2019-D-4247-0087","regulation_id_number":null,"title":"Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Draft Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","checked_regulationsdotgov_at":"2022-03-01T04:30:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11077,"subtype":null,"title":"Patient-Focused Drug Development: Methods To Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; Availability","toc_doc":"Patient-Focused Drug Development: Methods to Identify What is Important to Patients","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":87}