written on 15.04.2014

GDUFA and the API Industry – One Year Later


Following the 2012 implementation of the Generic Drug User Fee Act (GDUFA), I wrote an article for CHEManager Europe’s July/August 2013 edition about GDUFA’s Impact on the API Industry. The article summarized the legislation and outlined the FDA’s intended outcomes along with other potential consequences resulting from the new regulations and associated fees. The legislation […]