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U.S. Department of Health and Human Services

Drugs

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CDER Small Business Webinar: Generic Drug User Fee Amendments of 2012 (GDUFA) - Self-identification Requirement - Discussion and Demonstration

The Food and Drug Administration, Center for Drug Evaluation and Research (CDER) Small Business Assistance Program is pleased to inform you of a unique opportunity for small business entities to learn more about the FDA and basic drug regulation. Our webinar series highlights various aspects of drug regulation.

GDUFA requires owners of facilities producing, or intending to produce, human generic drugs, active pharmaceutical ingredients, and certain other sites and organizations that support the manufacture or approval of these products to provide identification information annually to FDA. 
 
Self-identification is distinct from the requirement to register and list (under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act), though the process for submitting information is similar. 
 
The fiscal year 2013 self-identification reporting period opened at the beginning of October and closes on December 3, 2012.
 
We were pleased to offer two separate webinar sessions – each session discussed who needs to self-identify and demonstrated the process of self-identification.  These webinars also included a live question and answer period (via Adobe Connect).
 
Both webinars provided the same content.
 
The archived webinars (audio and video) are now available in the box below.
 
Our presenters were:
  • Harry Schwirck from our Office of Compliance (OC) -- Who Should Self-ID
  • Gene Poole, David Baldwin and Travis Haney, CNIPS -- How to Self-ID
  • CDR Cheryl Ford and Monica Bali from our Office of Business Informatics (OBI) -- Questions and Answers
 
Staff is available at 1- 866-405-5367 or at askGDUFA@fda.hhs.gov to answer any other questions.
For More Information:
http://www.fda.gov/smallbusinessdrugs
Click on Workshops and Webinars in Spotlight box

If you've never used Connect Pro, get a quick overview: http://www.adobe.com/go/connectpro_overview
Test your connection prior to the day of the event: https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
 
Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
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