{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled \"Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.\" This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.","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/2011/12/30/2011-33550.html","cfr_references":[],"citation":"76 FR 82303","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on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 29, 2012. Submit written comments on the proposed collection of information by February 28, 2012.","disposition_notes":null,"docket_ids":["Docket No. FDA-2011-D-0868"],"dockets":[],"document_number":"2011-33550","effective_on":null,"end_page":82306,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2011/12/30/2011-33550.xml","html_url":"https://www.federalregister.gov/documents/2011/12/30/2011-33550/draft-guidance-for-industry-on-responding-to-unsolicited-requests-for-off-label-information-about","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2011-33550?publication_date=2011-12-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2011-12-30/2011-33550/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":3405,"last_updated":"2026-04-03 16:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2011-12-30/pdf/2011-33550.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2011-33550.pdf?1325166621","publication_date":"2011-12-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2011/12/30/2011-33550.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2020-04-30T03:30:19Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":82303,"subtype":null,"title":"Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability","toc_doc":"Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices","toc_subject":"Draft Guidance for Industry; Availability:","topics":[],"type":"Notice","volume":76}