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 · 2021/4/91 分で読めます
Lavipharm Laboratories, Inc., et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
ローカル自動翻訳 · 情報源の原言語
概要
The Food and Drug Administration (FDA) is withdrawing approval of five abbreviated new drug applications (ANDAs) from multiple holders of those ANDAs. The basis for the withdrawal is that these ANDA holders have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS).
情報源の原言語: Federal Register — Food and Drug Administration原文の発表を開く →