Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

Digital submission of adverse event reports for investigational new drug applications reflects FDA’s ongoing modernization efforts

The U.S. Food and Drug Administration is taking steps towards requiring electronic submission of certain safety reports for products being evaluated by the FDA under an investigational new drug (IND) application into the FDA's Adverse Event Reporting System (FAERS). The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents. The changes will allow the FDA to access and review both pre- and post-market safety information in the same system and with the same data standard.

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