approvable letters meaning in English
可批准函
Examples
- An approvable letter indicates that fda is prepared to approve the application upon the satisfaction of conditions specified in the approvable letter
补正通知书表示，在满足补正通知书上的条件后， fda将准备批准该项申请。 - 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
补正通知书上申请的药品，只有等到企业提供了满意的补充资料，和其它fda可能追加的条件达到要求后，通过文字形式通报被批准，才可以上市。