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