{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a revised draft guidance for industry titled \"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.\" FDA has revised and is reissuing this draft guidance in response to public comments and to changes in drug development by focusing on generating rigorous scientific evidence in the most efficient manner. Advances in our understanding of biological processes and the increasing availability of high-quality data have transformed the evidentiary landscape for drug development. Given these advances, the draft guidance discusses the many factors that can impact the strength of evidence of effectiveness for a drug and clarifies how sponsors can rely on one adequate and well-controlled clinical investigation with confirmatory evidence to satisfy the substantial evidence of effectiveness standard. When final, this guidance will replace the 1998 guidance titled \"Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products.\"","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/2026/06/24/2026-12622.html","cfr_references":[],"citation":"91 FR 37994","comment_url":null,"comments_close_on":"2026-09-22","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by September 22, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No.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-2019-D-4964"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2026-06-24T11:56:58.651-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2019-D-4964-0076","allow_late_comments":false,"id":"FDA-2019-D-4964-0076","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2019-D-4964","title":"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability"}],"document_number":"2026-12622","effective_on":null,"end_page":37996,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/06/24/2026-12622.xml","html_url":"https://www.federalregister.gov/documents/2026/06/24/2026-12622/demonstrating-substantial-evidence-of-effectiveness-for-human-drug-and-biological-products-revised","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-12622?publication_date=2026-06-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-06-24/2026-12622/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":2178,"last_updated":"2026-09-22 12:15:07 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-06-24/pdf/2026-12622.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-12622.pdf?1782141309","publication_date":"2026-06-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/06/24/2026-12622.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-4964","supporting_documents_count":0,"docket_id":"FDA-2019-D-4964","document_id":"FDA-2019-D-4964-0076","regulation_id_number":null,"title":"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2026-06-25T18:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":37994,"subtype":null,"title":"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Revised Draft Guidance for Industry; Availability","toc_doc":"Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products","toc_subject":"Guidance","topics":[],"type":"Notice","volume":91}