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

October 29, 2019 – 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 The planned process for submissions is outlined in a new draft guidance, and the FDA is also making available supporting technical specification documents.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 … (leggi tutto)