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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
ysis and assessment of the drug product and manufacturing quality. We also, where needed, conduct premarket inspections of manufacturing facilities for the product to ensure compliance with good manufacturing practice regulations and other quality requirements before it is ever marketed. For generic drugs in particular, this includes all the assessment activities conducted by our Office of Generic Drugs as part of their multidisciplinary review of all generic drug applications. As a result of th

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