IPEC-Americas Presents Two Key Excipient Topics at FDA GDUFAMeetingPart I of 2-Part Series – Novel Excipients Topic

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