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Statement from FDA on continuing efforts to maintain its strong oversight of generic drugs
date:Feb 25, 2019
e FDAs rigorous review of manufacturing information, many drugs are not allowed to be marketed because, based on our careful review and analysis, they do not meet the standards for approval.

Before and after marketing of a drug product, manufacturers are also required to notify the FDA of any changes they make to their manufacturing process or facilities. Moderate and significant changes require a supplemental application to be submitted to the FDA and significant manufacturing changes require

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