Keyword: Michael Glessner

GDUFA’s Impact on the API Industry – an Update

02.04.2014 - The Price of Doing Business - Following the 2012 implementation of the Generic Drug User Fee Act (GDUFA), an article in CHEManager Europe's July/August 2013 edition about GDUFA's...

Plant Construction & Process Technology

GDUFA’s Impact on the API Industry

06.08.2013 - One-Time Fee - On Oct. 1, 2012, the U. S. Food and Drug Administration (FDA) implemented the long-discussed Generic Drug User Fee Act (GDUFA) , thereby authorizing the agency to...