{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled \"M4E(R2): The CTD-- Efficacy\" (M4E(R2)). The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). In August 2001, FDA made available guidance on preparing the efficacy components of an application file in the common technical document (CTD) format (\"M4E: The CTD--Efficacy\" (M4E guidance)). This draft guidance revises the M4E guidance. The revised draft guidance standardizes the presentation of benefit-risk information in regulatory submissions, providing greater specificity on the format and structure of benefit-risk information. This revision is intended to facilitate communication among regulators and industry.","action":"Notice.","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/2015/10/02/2015-25122.html","cfr_references":[],"citation":"80 FR 59785","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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by December 1, 2015.","disposition_notes":null,"docket_ids":["Docket No. FDA-2015-D-3235"],"dockets":[],"document_number":"2015-25122","effective_on":null,"end_page":59786,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/10/02/2015-25122.xml","html_url":"https://www.federalregister.gov/documents/2015/10/02/2015-25122/m4er2-the-common-technical-document-efficacy-international-conference-on-harmonisation-draft","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-25122?publication_date=2015-10-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-10-02/2015-25122/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1222,"last_updated":"2026-09-21 20:15:12 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-10-02/pdf/2015-25122.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-25122.pdf?1443703647","publication_date":"2015-10-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/10/02/2015-25122.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2015-D-3235","supporting_documents_count":0,"docket_id":"FDA-2015-D-3235","regulation_id_number":null,"title":"M4E(R2): The Common Technical Document--Efficacy; International Conference on Harmonisation; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2015-12-02T05:00:38Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":59785,"subtype":null,"title":"M4E(R2): The Common Technical Document-Efficacy; International Conference on Harmonisation; Draft Guidance for Industry; Availability","toc_doc":"M4E(R2)The Common Technical DocumentEfficacy; International Conference on Harmonisation","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}