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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ble to the drug (vs. an underlying condition, for example). Moreover, reports typically have limited information for fully analyzing causality. Numerous biases influence whether AEs are reported in the first place. For example, some patients and providers may have negative expectations about generic products, and there may be a bias to report AEs with generic products, particularly early during their marketing. The AE severity and publicity about a drug or AE can also influence reporting.

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07/07 15:56