By their count, first rounds for INDs, NDAs and ANDAs took an average of 39, 59 and 81 working days once they were accepted for priority review.
截至2019年4月,优先审查程序已受理559份申请。
As of April of 2019, the priority review process has already granted 559 applications.
FDA认为首仿药对公共健康很重要,并优先审查这些呈件。
FDA considers first generics to be important to public health, and prioritizes review of these submissions.
这项研究应当侧重于每个大陆若干具体国家的实例并优先审查已经运作或正在制定的系统和措施。
The study should focus on a few concrete national cases on each continent and give priority to the examination of systems and measures already in operation or being set up.
FDA已授予Orkambi孤儿药及突破性药物资格,并通过优先审查程序审批。
Orkambi received breakthrough and orphan drug designations and was approved through the priority review program.
指示委员会优先审查其涉及本决议规定、尤其是涉及上文第6、12、13、17、22和26段的准则;.
Directs the Committee, as a matter of priority, to review its guidelines with respect to the provisions of this resolution, in particular paragraphs 6, 12, 13, 17, 22, and 26 above;
Also directs the Committee, as a matter of priority, to review its guidelines with respect to the provisions of the present resolution, in particular paragraphs 10, 12, 14, 15, 17, 21, 23, 27, 28, 30, 33, 37 and 40;
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