{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled \"Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.\" The guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the guidance.","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/2012/02/24/2012-4288.html","cfr_references":[],"citation":"77 FR 11134","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on Agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2008-D-0610"],"dockets":[],"document_number":"2012-4288","effective_on":null,"end_page":11135,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2012/02/24/2012-4288.xml","html_url":"https://www.federalregister.gov/documents/2012/02/24/2012-4288/guidance-for-industry-on-postmarketing-adverse-event-reporting-for-medical-products-and-dietary","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2012-4288?publication_date=2012-02-24","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2012-02-24/2012-4288/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":863,"last_updated":"2026-10-25 10:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2012-02-24/pdf/2012-4288.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2012-04288.pdf?1330005384","publication_date":"2012-02-24","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2012/02/24/2012-4288.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"See FDA-2008-D-0610-0004","document_id":"FDA-2008-D-0610-0006"}],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2008-D-0610","supporting_documents_count":1,"docket_id":"FDA-2008-D-0610","regulation_id_number":null,"title":"Post marketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic","checked_regulationsdotgov_at":"2012-03-15T08:06:23Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":11134,"subtype":null,"title":"Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability","toc_doc":"Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic","toc_subject":"Guidance For Industry:","topics":[],"type":"Notice","volume":77}