资讯

腾讯网3 年
如何使新药上市申请（NDA/BLA）成功获得FDA批准
我们在本期《奥来恩专家解读》简要介绍FDA CDER对NDA或BLA审评的基本程序以及成功准备和申请的关键要素。由于NDA或BLA内容和审评过程很复杂 ...
腾讯网2 年
FDA 发布 CMC 批准后变更可比性方案定稿指南
美国 FDA 于 10 月 13 日发布了“NDA、ANDA 或 BLA 中化学、生产与控制信息批准后变更的可比性方案”定稿指南，以帮助企业通过使用可比性方案（CP ...
新浪网2 年
新药从研发到上市的全流程：IND、NDA、ANDA傻傻分不清
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 ...
新浪网1 年
【关注】近期国内创新药IND、NDA/BLA、获批上市及全球III期临床汇总
2024年2月，vorasidenib的上市申请（NDA）获FDA受理并授予优先审评 ... 维昇/ Ascendis的注射用隆培促生长素的上市许可申请（BLA）获CDE受理。
Investopedia3 年
Abbreviated New Drug Application (ANDA): What it is, How it Works
An Abbreviated New Drug Application (ANDA) is a written request to the U.S. Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States. Abbreviated New Drug ...
Business Wire7 年
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA ...
DUBLIN--(BUSINESS WIRE)--The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official" conference has been added to ResearchAndMarkets.com's offering.
Business Wire7 年
Two Day Workshop - eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM ...
DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (COM)" conference to their offering. The ...
Pharm Exec3 年
FDA User Fees To Rise – and Fall – as New Fee Agreements Move Forward
Biopharmaceutical companies will pay more than $3 million to file an application seeking FDA approval of a new drug (NDA) or biologic (BLA) during fiscal year 2022 ... Filing an abbreviated new drug ...
Business Insider5 年
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: In-Depth Review of the ...
DUBLIN, Aug. 29, 2019 /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. This two day workshop ...
Finanznachrichten7 年
2-Day Workshop by Ex-FDA Official: eCTD Submissions of IND and NDA/BLA to the US FDA, EU ...
The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official" conference has been added to Research and Markets' offering. The international agreement ...