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.
