Search Results for pre-ANDA meetings

Showing 1 – 1

FDA Launches New Online Portal for Requesting Pre-ANDA Meetings By Zachary Brennan - Published 05 October 2017

Thanks to the new Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) this week launched a new online platform to allow industry to request pre-ANDA (abbreviated new drug application) meetings for complex generic drugs. 

Categories: News, US, CDER, Generic drugs

Tags: pre-ANDA meetings, FDA Direct NextGen Collaboration Portal