资讯

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。
腾讯网10 个月
明日下午3点！准备NDA/BLA时的重要考量
拥有逾25年的医药产品注册经验，曾在全球知名药企和cro公司负责注册事务超过15年，主导完成沟通交流会申请、ind、nda和补充申请等200多项中美两地 ...
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 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 ...
JD Supra6 年
FDA publishes final guidance on ANDA/505(b)(2) NDA pathways
On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance.