{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled \"A Risk- Based Approach to Monitoring of Clinical Investigations--Questions and Answers.\" This guidance provides information on risk-based approaches to monitoring investigational studies of human drug and biological products, medical devices, and combination products. The guidance contains recommendations on planning a monitoring approach, developing the content of a monitoring plan, and addressing and communicating monitoring results. This guidance expands on the guidance for industry entitled \"Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring\" (August 2013) by providing additional information to facilitate sponsors' implementation of risk-based monitoring. This guidance finalizes the draft guidance entitled \"A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers,\" issued on March 15, 2019.","action":"Notice of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/2023/04/12/2023-07687.html","cfr_references":[],"citation":"88 FR 22038","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The announcement of the guidance is published in the Federal Register on April 12, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2019-D-0362"],"dockets":[{"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":"2023-04-12","updated_at":"2023-04-12T08:57:17.698-04:00","comment_url":"https://www.regulations.gov/commenton/FDA_FRDOC_0001-12139","allow_late_comments":null,"id":"FDA_FRDOC_0001-12139","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA_FRDOC_0001","title":"Recently Posted FDA Rules and Notices."}],"document_number":"2023-07687","effective_on":null,"end_page":22040,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/04/12/2023-07687.xml","html_url":"https://www.federalregister.gov/documents/2023/04/12/2023-07687/a-risk-based-approach-to-monitoring-of-clinical-investigations-questions-and-answers-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-07687?publication_date=2023-04-12","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-04-12/2023-07687/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2536,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-04-12/pdf/2023-07687.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-07687.pdf?1681217129","publication_date":"2023-04-12","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/04/12/2023-07687.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"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"}],"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_FRDOC_0001","supporting_documents_count":0,"docket_id":"FDA_FRDOC_0001","document_id":"FDA_FRDOC_0001-12139","regulation_id_number":null,"title":"Recently Posted FDA Rules and Notices.","checked_regulationsdotgov_at":"2023-04-13T12:00:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":22038,"subtype":null,"title":"A Risk-Based Approach To Monitoring of Clinical Investigations-Questions and Answers; Guidance for Industry; Availability","toc_doc":"A Risk-Based Approach to Monitoring of Clinical InvestigationsQuestions and Answers","toc_subject":"Guidance for Industry:\n","topics":[],"type":"Notice","volume":88}