この記事の翻訳を準備しています。それまでの間、英語の原文を表示します。
ビジネス · 2024/8/81 分で読めます
Flamingo Pharmaceuticals Ltd.; Proposal To Withdraw Approval of Two Abbreviated New Drug Applications; Opportunity for a Hearing
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概要
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of two abbreviated new drug applications (ANDAs) and is announcing an opportunity for the ANDA holder to request a hearing on this proposal. The basis for the proposal is that the ANDA holder has repeatedly failed to file required annual reports for those ANDAs.
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →