Status Updates for ANDAs: FDA Spells Out GDUFA II Provision
By Zachary Brennan -
Published 06 October 2017
Under the second iteration of the Generic Drug User Fee Act (GDUFA II), the US Food and Drug Administration (FDA) has agreed to provide timely abbreviated new drug application (ANDA) review status updates for all pending ANDAs.
Categories: News, US, FDA, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration
Tags: GDUFA II, ANDA status updates