first filing acceptance

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16:15 Mar 15, 2018
This question was closed without grading. Reason: Other

English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: first filing acceptance
The application is seeking approval for KEYTRUDA as a treatment for patients with advanced cervical cancer with disease progression on or after chemotherapy.

This is the first filing acceptance and Priority Review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA.
Maxim Polukhin
Local time: 10:19


Summary of answers provided
4here: from the day of acceptance of filing - со дня принятия заявки
Erzsébet Czopyk
4первая подача заявки
Vladys


  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5
первая подача заявки


Explanation:
Относительно «новизны» активного ингредиента не уточняется, имеется ли в виду первая подача заявки в стране или в мире. https://www.apteka.ua/article/3531

Vladys
Ukraine
Local time: 10:19
Works in field
Native speaker of: Native in RussianRussian
PRO pts in category: 62

Peer comments on this answer (and responses from the answerer)
neutral  Evgeni Kushch: acceptance смущает, ее, видимо, приняли на рассмотрение и придали статус приоритетного рассмотрения
16 hrs
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2 days 20 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
here: from the day of acceptance of filing - со дня принятия заявки


Explanation:
Your text:

FDA Grants Priority Review to Merck's Supplemental Biologics ...
https://www.dddmag.com/.../fda-grants-priority-review-mercks...
- This is the first filing acceptance and Priority Review granted for an anti-PD-1 therapy in cervical cancer and the 14th regulatory submission accepted by the FDA for KEYTRUDA. The FDA has set a PDUFA, or target action, date of June 28, 2018. “Advanced cervical cancer is an illness with a poor prognosis ...

http://ir.amicusrx.com/news-releases/news-release-details/us...

CRANBURY, N.J., Feb. 12, 2018 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for filing under priority review for the oral precision medicine migalastat HCl (“migalastat”) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA decision is August 13, 2018.

Migalastat previously received both Orphan Drug Designation and Fast Track designation from the U.S. FDA. The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists.

Приоритетный обзор FDA ускорит время обзора с 10 месяцев до полных шести месяцев со дня принятия заявки

Газета Поиск: Своими клетками
www.poisknews.ru/news/digest/27556/ - Translate this page
Jul 28, 2017 - Американское Управление по санитарному надзору за качеством пищевых продуктов и медикаментов (FDA)

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Note added at 2 days 20 hrs (2018-03-18 12:34:46 GMT)
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Thank you very much Evgeni, your remark was very helpful

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Note added at 2 days 20 hrs (2018-03-18 12:37:45 GMT)
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Создание нового торгового названия лекарства » Клиническая ...
clinical-pharmacy.ru/.../414-sozdanie-novogo-torgovogo-nazvaniy...
В состав группы входит 15 экспертов, которые в течение 18 мес ***с момента подачи заявки*** (this is just filing but not filing acceptance!)*** должны принять решение по предлагаемому торговому названию лекарственного средства. В отличие от FDA, которое опубликовало свои специальные критерии оценки торговых названий ...

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Note added at 2 days 20 hrs (2018-03-18 12:38:56 GMT)
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EMA и FDA приняли заявки на регистрацию применения ...
m.clinvest.ru/.../ema-i-fda-prinyali-zayavki-na-registratsiyu-primen... -
Управление по контролю за продуктами и лекарствами США (FDA) также приняло к рассмотрению заявку

Erzsébet Czopyk
Hungary
Local time: 09:19
Specializes in field
Native speaker of: Native in HungarianHungarian
PRO pts in category: 78
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