federal_register: 2011-94

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2011-94 Draft Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic." The draft guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during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products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the draft guidance. This draft guidance is a revision of the draft guidance for industry of the same title published on December 16, 2008. 2011-01-07 2011 1 https://www.federalregister.gov/documents/2011/01/07/2011-94/draft-guidance-for-industry-on-postmarketing-adverse-event-reporting-for-medical-products-and https://www.govinfo.gov/content/pkg/FR-2011-01-07/pdf/2011-94.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic." The draft guidance...  

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