Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports
AuroBlog - Aurous Healthcare Clinical Trials blog
APRIL 29, 2024
Clinical trial companies see immense relevance on US FDA Electronic Submission Safety Reports. The guidance provides instructions about how the individual case safety reports (ICSRs) from investigational new drug (IND) need to be supported with Adverse Event Reporting System (AERS).
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