FDA releases draft guidance “Providing Submissions in Electronic Format – Postmarketing Safety Reports”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US FDA has released a new draft guidance providing information on the electronic submission of postmarketing safety reports (ICSRs), attachments to ICSRs and other postmarketing safety reports.
This draft guidance revises and replaces the draft guidance for industry entitled “Providing Regulatory Submissions in Electronic Format – Postmarketing Individual Case Safety Reports”, issued on June 12, 2008.
The document is being distributed for comment purposes only.
The technical specification associated with this guidance, Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments, is provided in a separate document and can be found on the FAERS Electronic Submissions Web page
Categories: Pharmacovigilance | Tags: Regulations