{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report.'' The purpose of this guidance document is to clarify requirements for postmarketing safety reporting. This guidance document is intended to improve the quality of safety reports submitted to FDA while streamlining the postmarketing surveillance of human drug and licensed biological products.","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/1997/08/27/97-22790.html","cfr_references":[],"citation":"62 FR 45425","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Written comments may be submitted at any time.","disposition_notes":null,"docket_ids":["Docket No. 97D-0345"],"dockets":[],"document_number":"97-22790","effective_on":null,"end_page":45426,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":null,"html_url":"https://www.federalregister.gov/documents/1997/08/27/97-22790/guidance-for-industry-on-postmarketing-adverse-experience-reporting-for-human-drug-and-licensed","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/97-22790?publication_date=1997-08-27","mods_url":"https://www.govinfo.gov/metadata/granule/FR-1997-08-27/97-22790/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":472,"last_updated":"2026-10-23 06:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-1997-08-27/pdf/97-22790.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"1997-08-27","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/1997/08/27/97-22790.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-18T16:12:05Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":45425,"subtype":null,"title":"Guidance for Industry on Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report; Availability","toc_doc":null,"toc_subject":null,"topics":[],"type":"Notice","volume":62}