S&E Determinations

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FDA Reviews 20 Drug Products and Determines that They Were Not Discontinued for S&E Reasons

Once an approved NDA product is discontinued from marketing or withdrawn, the FDA must make a determination that the reason for such action by the innovator was not for safety or efficacy reasons (see 21 CFR 314.161(a)).  Such a determination must be made before an ANDA for a duplicate of the reference listed drug (RLD) […]

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