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Guidance Documents/Guidance-Document/Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments

Specifications for Preparing and Submitting Electronic ICSRs and ICSR Attachments

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

February 14, 2020

April 20, 2020

Center for Drug Evaluation and Research

77393f14-23b3-44f2-b22c-c43dbd63161a

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