优先审评 - 翻译成英语

• priority review

在 中文 中使用 优先审评 的示例及其翻译为 英语

该产品于4月23日以“具有明显治疗优势创新药”为由纳入优先审评。
The product was included in the priority review on March 28th on the grounds of“innovative medicine with obvious therapeutic advantages”.

该产品于4月23日以“具有明显治疗优势创新药”为由纳入优先审评。
The product was included in the priority review on November 7th for“innovative medicine with obvious therapeutic advantages”.

该药物的NDA在去年11月被FDA接受，并且被授予了优先审评资格。
The agency accepted the NDA in November, while also giving it priority review status.

该产品于4月23日以“具有明显治疗优势创新药”为由纳入优先审评。
The product was included in the priority review on April 23 as“innovative medicine with obvious therapeutic advantages”.

哌柏西利是我国首个获批上市的CDK4/6抑制剂，于2017年11月22日纳入优先审评。
Pipersilili is China's first approved CDK4/6 inhibitor and was included in the priority review on November 22, 2017.

我们使用四种特定的监管工具来确保快速有效地加快审批决策：快速通道资格，突破性疗法认定，加速审批和优先审评资格。
We use four specific regulatory tools to ensure prompt and efficient expedited review for approval decisions: Fast Track, Breakthrough, Accelerated Approval, and Priority Review.

作为继快速通道、加速批准、优先审评….
Fast Track, Accelerated Approval and Priority Review.

FDA授权这项申请快速通道指定和优先审评。
FDA granted this application priority review and fast track designation.

Xofluza在美国的新药申请获得了FDA授予的优先审评资格。
Xofluza's new drug application in the United States received the FDA's priority review.

其在中国、日本和美国的申请已根据"优先审评"计划进行了审核。
The applications in the Mainland China, Japan, and the US were reviewed under the Priority Review program.

在上市申请得到接受后，美国FDA也曾授予其优先审评资格。
After its listing application was accepted, the US FDA also granted its priority for assessment.

符合其它加快审评计划（例如，快速通道、优先审评）标准的药也可以加以考虑。
Drugs meeting other criteria for other expedited programs(e.g. fast track, priority review) may also be considered.

年5月17日，FDA发布了医疗器械上市申请的优先审评（PriorityReview）途径。
On May 17, 2013, FDA issued a guidance document regarding priority review of premarket submissions for devices.

对上述重新申报的注册申请实行优先审评审批，批准上市后免于进行质量和疗效一致性评价。
The above-mentioned re-declared registration application will be subject to priority review and approval, and will be exempted from quality and efficacy consistency evaluation after approval.

随后FDA建立了三个特别审批通道:快速通道（FastTrack）、优先审评（PriorityReview）、加速批准（AcceleratedApproval）。
The FDA has three additional fast routes to approval: fast track, priority review, and accelerated approval.

Kite已于2017年5月29日获得了美国食品药品监督管理局的优先审评，《处方药使用者费用法案》的决定日期为2017年11月29日。
Kite received priority review on May 29, 2017 with the Prescription Drug User Fee Act action date set for November 29, 2017.

审评的优先政策.
Priority Review Guidance.

FDA曾授予Unituxin优先审评和孤儿药资格。
The FDA granted Unituxin priority review and orphan product designation.

优先审评.
Priority Review.

优先审评的时间为6个月。
Priority Review status is six months.