CDER Small Business and Industry Assistance (CDER SBIA) Webinar - Overview of GDUFA II and Implementation of GDUFA II User Fees - October 28, 2016

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The Food and Drug Administration, Center for Drug Evaluation and Research and Small Business and Industry Assistance (CDER SBIA), is pleased to announce the next webinar in our series.

The CDER SBIA webinars focus on a specific topic and provide an opportunity for small business and industry entities to learn more about the FDA and basic drug regulation. The webinars support CDER SBIA’s mission of promoting productive interaction with regulated industry by assisting small pharmaceutical business and industry with information relating to the development and regulation of human drug products.

On October 28, 2016, CDER SBIA hosted a LIVE webinar titled: Overview of GDUFA II and Implementation of GDUFA II User Fees

This 60 minute webinar provided a brief overview of changes to the user fee structure under GDUFA II and what it means for regulated industry. We discussed those changes to the user fee structure under GDUFA II and described 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 had a live Q and A session after the presentation.

The featured speakers were:

Donal Parks, Director
Division of User Fee Management and Budget Formulation
Office of Management (OM)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration (FDA)

Gisa Perez, Branch Chief, Generics
Division of User Fee Management and Budget Formulation
OM | CDER | FDA

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

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


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Page Last Updated: 11/10/2016
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