approvable letters 中文意思是什麼

approvable letters 解釋
可批準函
  1. Drug products which are the subject of approvable letters may not be legally marketed until the firm has satisfied the identified deficiencies, as well as any other requirements that may be imposed by fda, and has been notified in writing that the application has been approved

    補正通知書上申請的藥品,只有等到企業提供了滿意的補充資料,和其它fda可能追加的條件達到要求后,通過文字形式通報被批準,才可以上市。
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