资讯

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。
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 Insider6 年
Two Day Seminar: eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Newark ...
The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering. The international agreement to assemble all Quality ...
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“Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance.