{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled \"Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs.\" This revised draft guidance, when finalized, will assist manufacturers, packers, and distributors (firms) of human prescription drugs and biologics with meeting the brief summary requirement for prescription drug advertising and the requirement that adequate directions for use be included with promotional labeling for prescription drugs when print materials are directed toward consumers. FDA is also announcing the withdrawal of the draft guidance for industry entitled \"Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.\"","action":"Notice of availability; withdrawal.","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/2015/02/09/2015-02527.html","cfr_references":[],"citation":"80 FR 6998","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this revised draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the revised draft guidance by May 11, 2015. Submit either electronic or written comments on the proposed collection of information by April 10, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2004-D-0500 (Formerly Docket No. 2004D-0042)"],"dockets":[],"document_number":"2015-02527","effective_on":null,"end_page":7000,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/09/2015-02527.xml","html_url":"https://www.federalregister.gov/documents/2015/02/09/2015-02527/brief-summary-and-adequate-directions-for-use-disclosing-risk-information-in-consumer-directed-print","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-02527?publication_date=2015-02-09","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-09/2015-02527/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":1377,"last_updated":"2026-04-04 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-09/pdf/2015-02527.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-02527.pdf?1423230867","publication_date":"2015-02-09","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/09/2015-02527.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement","document_id":"FDA-2004-D-0500-0009"},{"title":"Example of Fictional Highlights of Prescribing Information (Based on Proposed Physician Labeling Rule) Translated in Consumer-Friendly Language and Formatted for Use in Consumer-Directed Advertisement","document_id":"FDA-2004-D-0500-0008"},{"title":"Example of Fictional Highlights of Prescribing Information\n(Based on Proposed Physician Labeling Rule) Background Material re Draft Guidance for Industry Help Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms \nFDA","document_id":"FDA-2004-D-0500-0007"},{"title":"Example of Fictional Highlights of Prescribing Information\n(Based on Proposed Physician Labeling Rule) Background Material re Draft Guidance for Industry Help Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms \nFDA","document_id":"FDA-2004-D-0500-0006"},{"title":"Draft Guidance for Industry Help Seeking and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms","document_id":"FDA-2004-D-0500-0003"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2004-D-0500","supporting_documents_count":5,"docket_id":"FDA-2004-D-0500","regulation_id_number":null,"title":"Guidances for Industry on Improving Direct-to-Consumer Advertising for Medical Products","checked_regulationsdotgov_at":"2015-05-12T05:00:20Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":6998,"subtype":null,"title":"Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs; Revised Draft Guidance for Industry; Availability","toc_doc":"Brief Summary and Adequate Directions for UseDisclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}