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Guidance on Electronic Postmarketing Reports

06/12/2008

Federal Register Notice: FDA is making available a draft guidance for industry, Providing Regulatory Submissions in Electronic Format Postmarketing — Individual Case Safety Reports. It consolidates and revises information in two existing draft guidances on electronic submission of postmarketing individual case safety reports (ICSRs) and attachments to ICSRs. To download the draft guidance, click here. To view this notice, click here.

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