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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
pidemiologic studies, electronic healthcare databases, estimates of drug usage and adverse drug experience reporting rates, estimates of background rates of the adverse events, the pharmacology of the drug in relation to the identified safety concern, and other relevant information.

If a potential safety concern is identified in FAERS, further evaluation is performed. This might include conducting studies using other large databases, such as those available in the Sentinel System, which compris

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