Drug Information Update- CDER Small Business Webinar on GDUFA Self-identification Requirement Discussion & Demonstration

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.

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CDER Small Business Webinar: GDUFA Self-identification Requirement - Discussion and Demonstration 

We are pleased to offer two separate webinar sessions – each session will discuss who needs to self-identify and demonstrate the process of self-identification. These webinars will also include a live question and answer period (via Adobe Connect). Both webinars will provide the same content. 

The archived webinars (audio and video) will be available on this website approximately 48 hours after each event. 

Our presenters will be: 

- Harry Schwirck from our Office of Compliance (OC) -- Who Should Self-ID

- Gene Poole, CNIPS, David Baldwin and Travis Haney, CNI -- How to Self-ID

- CDR Cheryl Ford and Monica Bali from our Office of Business Informatics (OBI) -- Questions and Answers

For more information, please visit: GDUFA Self ID Webinar.

November 19, 2012 from 07:00 – 08:00 am EST  This session and time is intended to accommodate our international audience, but anyone can participate To register for this Event, please go the following link: https://collaboration.fda.gov/gdufa1119/event/registration.html (Registration password needs to be 8 characters and alphanumeric) Web Address for Viewing: https://collaboration.fda.gov/gdufa1119/event/login.html (Presentation will last approximately 1 hr) Call in Numbers (listen only) : Dial in Numbers (PDF - 24KB) If your country does not appear on this list, then please use the USA Toll Number. Password (verbal): GDUFA

 November 20, 2012 from 11:00 am – 12:00 pm EST. 

• This session is intended to accommodate our domestic audience, but anyone can participate.
• To register for this Event, please go the following link: https://collaboration.fda.gov/gdufa1120/event/registration.html (Registration password needs to be 8 characters and alphanumeric)

• Web Address for Viewing: https://collaboration.fda.gov/gdufa1120/event/login.html

(Presentation will last approximately 1 hr)

• Call in Numbers (listen only): Dial in Numbers (PDF - 24KB)
• If your country does not appear on this list, then please use the USA Toll Number.

Password (verbal): DOMESTIC