CDER SBIA Webinar - Overview of GDUFA II and Implementation of GDUFA II User Fees - October 28, 2016

On October 28, 2016, 1 PM EST, CDER SBIA will host a LIVE webinar titled:

Overview of GDUFA II and Implementation of GDUFA II User Fees

This 60 minute webinar will provide a brief overview of changes to the user fee structure under GDUFA II and what it means for regulated industry. We will discuss those changes to the user fee structure under GDUFA II and will describe how CDER and Industry can best prepare for GDUFA II go-live on October 1, 2017.

We are very interested in addressing any questions or concerns and we will have a live Q and A session after the presentation.

This event has been pre-approved by RAPS as eligible for up to 1 credit towards a participant’s RAC recertification upon full completion.

Related Resource: Generic Drug User Fee Amendments of 2012

For questions concerning the webinar, please contact CDER SBIA at: (866)-405-5367 | (301)-796-6707