Providing Submissions in Electronic Format-Postmarketing Safety Reports; Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Submissions in Electronic Format--Postmarketing Safety Reports." This guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drugs, biological products, and combination products. This guidance finalizes the revised draft guidance entitled "Providing Submissions in Electronic Format-- Postmarketing Safety Reports," issued in June 2014.
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