By Adam Pierson (October 13, 2021, 5:10 p.m. EDT) – Federal regulations require manufacturers of pharmaceutical and medical devices to monitor information on their approved products. If this information meets certain criteria, the manufacturer must forward it to the United States Food and Drug Administration through an adverse event report.
These reports – and those submitted directly by the public or health professionals – are then hosted in separate databases accessible to the public. But the number of reports is growing at a tremendous rate and the information they contain can be misleading or incomplete.
In the FDA adverse event reporting system, or FAERS, for example, the number of reports regarding …
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