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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
e quality and safety of generic and brand drugs is having a clear understanding of the specific processes and technologies used to manufacture drugs throughout their lifecycle. This starts before a drug is even approved and brought to market, with the FDAs premarket (or preapproval) review of drug applications, including a robust review of manufacturing information, which is a cornerstone of our current regulatory framework. This manufacturing information allows the FDA to perform a careful anal

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