Examples of using Priority review in English and their translations into Chinese
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Fascioliasis is recognised by the FDA as a neglected tropical disease, triggering the award of a Priority Review Voucher based upon this approval.
Priority review vouchers initially covered neglected tropical diseases like Chagas, or sleeping sickness.
This is the 13th rare paediatric disease priority review voucher issued by the FDA since the program began.
Along with the NDA submission, Acer has requested Priority Review, which if granted, could result in a six-month review period.
In November 2019, the NDA was accepted for review by the NMPA(clinicaltrials. gov identifier: NCT02588170) and subsequently granted Priority Review status.
Drugs that receive this designation are eligible for more frequent interactions with the FDA, priority review and rolling review of the Biologics License Application(BLA).
As part of its QIDP designation, Orbactiv was given priority review, which provides an expedited review of the drug's application.
We believe that galactosemia may qualify for accelerated approval, as well as for the rare pediatric disease priority review voucher, or RPD-PRV, program.
This is the 13th rare paediatric disease priority review voucher issued by the FDA since the programme began.
In December 2017, FDA accepted the Rubraca supplemental New Drug Application(sNDA) application and granted priority review status.
This is the 13th rare paediatric disease priority review voucher issued by the FDA since the program began.
This is the first product to be awarded a Material Threat Medical Countermeasure priority review voucher.
Agree Cochrane's future priority review types, methods, and data sources through the development of a'content strategy', and begin associated implementation activities.
Approved priority review requests are allocated resources by the NMPA Center for Drug Evaluation(CDE) and additional channels to facilitate timely feedback from regulators.
This application received priority review by the FDA and was approved under the designation of orphan drug.
FDA's priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure".
The application is based on data from the combined interim analysis of two large US trials, 4 and Genentech has received a priority review designation.
Alternatively, they can sell the voucher to other companies, who may then apply for priority review of any drug.
On May 17, 2013, FDA issued a guidance document regarding priority review of premarket submissions for devices.
We use four specific regulatory tools to ensure prompt and efficient expedited review for approval decisions: Fast Track, Breakthrough, Accelerated Approval, and Priority Review.