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商业 · 2021/3/31 分钟阅读
PolyMedica Industries Inc., et al.; Proposal To Withdraw Approval of Three New Drug Applications; Opportunity for a Hearing
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摘要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of three new drug applications (NDAs) and is announcing an opportunity for the NDA holders to request a hearing on this proposal. The basis for the proposal is that the NDA holders have repeatedly failed to file required annual reports for those NDAs.
来源原始语言: Federal Register — Food and Drug Administration打开原始公告 →