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Real-time AE Reporting
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Real-time AE Reporting
I thought it was interesting that FDA will now report AEs real-time. I actually thought it was currently updated monthly, but looks like it was historically quarterly! https://www.fda.gov/news-events/press-announcements/fda-begins-real-time-reporting-adverse-event-data
fda.gov
FDA Begins Real-Time Reporting of Adverse Event Data
The U.S. Food and Drug Administration (FDA) today began publishing adverse event data on a daily basis, giving the public faster access to information on serious medication errors and product quality complaints for prescription drugs and therapeutic biologics.
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I am really interested to see if/how this impacts manufacturers reporting practices, especially considering all of the details are not usually available when the initial report is made. Something to keep a pulse on for sure.
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