FDA releases draft guidance “Providing Submissions in Electronic Format – Postmarketing Safety Reports”

June 14, 2014 by Moin Don

US FDA has released a new draft guidance providing information on the electronic submission of postmarketing safety reports (ICSRs), attachments to ICSRs and other postmarketing safety reports. This draft guidance revises and replaces the draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format