Zdrowie i gospodarka · 10.06.2014
Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Providing Submissions in Electronic Format--Postmarketing Safety Reports." This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs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 drug and biological products. We are issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule.