{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of three guidances for industry entitled \"Premarketing Risk Assessment,\" \"Development and Use of Risk Minimization Action Plans,\" and \"Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.\" These guidances provide guidance to industry on risk management activities for drug products, including biological drug products, in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). The guidances address, respectively, premarket risk assessment; the development, implementation, and evaluation of risk minimization action plans for drug products; and good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data.","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/2005/03/29/05-6200.html","cfr_references":[],"citation":"70 FR 15866","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit written or electronic comments on agency guidances at any time.","disposition_notes":null,"docket_ids":["Docket Nos. 2004D-0187, 2004D-0188, and 2004D-0189"],"dockets":[],"document_number":"05-6200","effective_on":null,"end_page":15867,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2005/03/29/05-6200.xml","html_url":"https://www.federalregister.gov/documents/2005/03/29/05-6200/guidances-for-industry-on-premarketing-risk-assessment-development-and-use-of-risk-minimization","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/05-6200?publication_date=2005-03-29","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2005-03-29/05-6200/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1998,"last_updated":"2026-09-23 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2005-03-29/pdf/05-6200.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2005-03-29","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2005/03/29/05-6200.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2011-11-12T15:50:46Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":15866,"subtype":null,"title":"Guidances for Industry on Premarketing Risk Assessment; Development and Use of Risk Minimization Action Plans; and Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment; Availability","toc_doc":"Premarketing risk assessment; risk minimization action plans, development and use; and good pharmacovigilance practices and pharmacoepidemiologic assessment","toc_subject":"Reports and guidance documents; availability, etc.:","topics":[],"type":"Notice","volume":70}