Posts tagged with "GDUFA"



22. July 2015
On June 15, 2015, FDA held a public meeting to seek input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). IPEC-Americas representative, David R. Schoneker, Director, Global Regulatory Affairs, Colorcon, IPEC-Americas Past Chairman and current Vice-Chair for User and Maker Relations, presented comments during the meeting. http://multibriefs.com/briefs/ipec/GDUFA_Article_R.pdf