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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ether a particular manufacturers product is causing more adverse events than another manufacturers product, just from adverse event reports. Additionally, analyses of voluntary, spontaneous adverse event reports from the FDA Adverse Event Reporting System (FAERS) whether using the public database, or reports received through a public records request cannot provide the actual rate of an adverse event (AE) for any drug.

The FAERS database includes reports regardless of whether AEs are attributa

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