IPEC-Americas Submits Comments on GDUFA

News category: 
Wednesday, July 15, 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.

There were two key issues on which the presentation and comments centered:

1) review and qualification of novel excipients; and

2) improvements in the inactive ingredient database (IID) and policies on how families of related excipients can be referenced in abbreviated new drug applications (ANDAs).

The comments can be accessed HERE.

Mr. Schoneker also attended the July 15 PDUFA public meeting and members of the IPEC-Americas FDA/IPEC-Americas/GPhA IID subcommittee will meet with FDA on July 30, 2015 to continue their discussion related to FDA’s safety review and evaluation of “families of excipients”.