{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled \"Geriatric Information in Human Prescription Drug and Biological Product Labeling.\" This draft guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling. The goal of this draft guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs and biological products in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients. This draft guidance provides additional examples of geriatric use statements in labeling and examples of when the labeling regulations authorize FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection. We are withdrawing the guidance for industry entitled \"Content and Format for Geriatric Labeling\" (October 2001) and replacing it with this draft guidance.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2020/09/16/2020-20435.html","cfr_references":[],"citation":"85 FR 57864","comment_url":null,"comments_close_on":"2020-11-16","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by November 16, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2020-D-1621"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":15,"comment_start_date":"2020-09-16","updated_at":"2023-02-28T22:46:38.150-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2020-D-1621-0001","allow_late_comments":null,"id":"FDA-2020-D-1621-0001","comment_end_date":"2020-11-17","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2020-D-1621","title":"Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability"}],"document_number":"2020-20435","effective_on":null,"end_page":57866,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2020/09/16/2020-20435.xml","html_url":"https://www.federalregister.gov/documents/2020/09/16/2020-20435/geriatric-information-in-human-prescription-drug-and-biological-product-labeling-draft-guidance-for","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2020-20435?publication_date=2020-09-16","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2020-09-16/2020-20435/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":778,"last_updated":"2026-07-28 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2020-09-16/pdf/2020-20435.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2020-20435.pdf?1600173939","publication_date":"2020-09-16","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2020/09/16/2020-20435.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_count":15,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2020-D-1621","supporting_documents_count":0,"docket_id":"FDA-2020-D-1621","document_id":"FDA-2020-D-1621-0001","regulation_id_number":null,"title":"Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2023-03-01T03:46:37Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":57864,"subtype":null,"title":"Geriatric Information in Human Prescription Drug and Biological Product Labeling; Draft Guidance for Industry; Availability","toc_doc":"Geriatric Information in Human Prescription Drug and Biological Product Labeling","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":85}