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收集周期:3.4-3.8,国内部分为首次申请临床、首次申请上市、首次批准上市的创新药 3月5日,罗氏的Vixarelimab注射液的临床申请获CDE受理。Vixarelimab ...
新药上市获批 NDA 1、勃林格殷格翰:佩索利单抗注射液 作用机制:靶向IL-36R抗体 适应症:泛发性脓疱型银屑病 3月6日,勃林格殷格翰的佩索利单抗 ...
主题: 准备NDA/BLA时的重要考量 主讲人: 陈伟 先生 康德弘翼执行主任、法规事务部负责人 李小贝 女士 康德弘翼临床统计编程高级经理 ...
以万络为例,1998年11月23日万络提交NDA 申请,编号 21-042,“1999 年 5 月 20 日获 FDA 批准,历时 178 天。 另外,ANDA的英文全称为Abbreviated New Drug ...
An Abbreviated New Drug Application (ANDA) is a written request to the U.S. Food and Drug Administration to manufacture and market a generic drug in the United States.
Join our comprehensive FDA regulatory course to navigate submissions for INDs, NDAs, ANDAs, and 505(b)(2). Gain insights into FDA processes, recent changes, and strategic needs, featuring expert-led ...
Specifically, NDA/ANDA holders are required to review information about their products in the current edition of Orange Book and then submit the one-time Marketing Status Report, in writing, to ...
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Newark, NJ, United States - November 8th-9th, 2018) - ResearchAndMarkets.com ...
NRx Pharmaceuticals, Inc. (Nasdaq: NRXP), a clinical-stage biopharmaceutical company, today announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U ...
Two Day Workshop - eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM) (Philadelphia, PA, United States - November 2-3, 2017) - Research and Markets ...
Dublin, Oct. 16, 2019 (GLOBE NEWSWIRE) -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering.
DUBLIN, Sept. 17, 2018 /PRNewswire/ -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada " conference has been added to ResearchAndMarkets.com's offering.
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