Novartis, UCSF researchers urge FDA to clean up its messy adverse events database
A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the FDA’s adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions.
In a paper appearing in eLife earlier this month (titled: Reverse translation of adverse event reports paves the way for de-risking preclinical off-targets) the researchers say such changes could help address several major challenges to interpreting data in FDA’s adverse event reporting system known as FAERS.
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