{"abstract":"The Food and Drug Administration (FDA) is amending its regulations on access to investigational new drugs for the treatment of patients. The final rule clarifies existing regulations and adds new types of expanded access for treatment use. Under the final rule, expanded access to investigational drugs for treatment use is available to individual patients, including in emergencies; intermediate-size patient populations; and larger populations under a treatment protocol or treatment investigational new drug application (IND). The final rule is intended to improve access to investigational drugs for patients with serious or immediately life-threatening diseases or conditions who lack other therapeutic options and who may benefit from such therapies. Elsewhere in this issue of the Federal Register, FDA is publishing the final rule on Charging for Investigational Drugs Under an Investigational New Drug Application which clarifies the circumstances in which charging for an investigational drug in a clinical trial is appropriate, sets forth criteria for charging for an investigational drug for the different types of expanded access for treatment use described in this final rule, and clarifies what costs can be recovered for an investigational drug.","action":"Final rule.","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/2009/08/13/E9-19005.html","cfr_references":[{"chapter":null,"citation_url":null,"part":312,"title":21},{"chapter":null,"citation_url":null,"part":316,"title":21}],"citation":"74 FR 40900","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective October 13, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2006-N-0238"],"dockets":[],"document_number":"E9-19005","effective_on":"2009-10-13","end_page":40945,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/08/13/E9-19005.xml","html_url":"https://www.federalregister.gov/documents/2009/08/13/E9-19005/expanded-access-to-investigational-drugs-for-treatment-use","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-19005?publication_date=2009-08-13","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-08-13/E9-19005/mods.xml","not_received_for_publication":null,"page_length":46,"page_views":{"count":3670,"last_updated":"2026-08-26 18:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-08-13/pdf/E9-19005.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-08-13","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/08/13/E9-19005.txt","regulation_id_number_info":{"0910-AF14":{"issue":"200904","html_url":"https://www.federalregister.gov/regulations/0910-AF14/expanded-access-to-investigational-drugs-for-treatment-use","title":"Expanded Access to Investigational Drugs for Treatment Use","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=200904&RIN=0910-AF14&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AF14"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"OMB Changes of the Proposed Rule FDA Regulations Policy and Management Staff to the Division of Dockets Management","document_id":"FDA-2006-N-0238-0018"},{"title":"Reference 1 OMB Changes of FDA Regulations Policy and Management Staff to the Division of Dockets Management","document_id":"FDA-2006-N-0238-0017"},{"title":"Attachment 2 Human Botulism Immune Globulin for the Treatment of Infant Botulism re Comment from California Department of Health Services","document_id":"FDA-2006-N-0238-0010"},{"title":"Attachment 1 Creation and Development of the Public Service Orphan Drug Human Botulism Immune Globulin re Comment from California Department of Health Services","document_id":"FDA-2006-N-0238-0008"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2006-N-0238","supporting_documents_count":4,"docket_id":"FDA-2006-N-0238","regulation_id_number":null,"title":"Expanded Access to Investigational Drugs for Treatment Use","checked_regulationsdotgov_at":"2009-09-01T14:23:36Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":40900,"subtype":null,"title":"Expanded Access to Investigational Drugs for Treatment Use","toc_doc":"Expanded Access to Investigational Drugs for Treatment Use","toc_subject":null,"topics":["Administrative practice and procedure","Drugs","Exports","Imports","Investigations","Labeling","Medical research","Reporting and recordkeeping requirements","Safety"],"type":"Rule","volume":74}