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U.S. Department of Health and Human Services

Drugs

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CDER Forum for International Drug Regulatory Authorities, April 19-23, 2010, College Park, MD

The Center for Drug Evaluation and Research (CDER) will be presenting a revamped CDER Forum for International Drug Regulatory Authorities (CDER Forum) on April 19-23, 2010. In the past, CDER Forums provided an overview of CDER Offices.  The April CDER Forum will place a greater emphasis on the review process. Specifically, CDER review disciplines will discuss a review that is posted on CDER’s Drugs@FDA website. 

The product chosen for discussion is saxagliptin (NDA 22-350).  It will serve as a platform to discuss CDER’s review process.  In addition, case studies of other submissions will be provided to address difficult review issues. Since the program will be interactive, it would be helpful if attendees are actively involved in the review process.  This revamped CDER Forum will provide opportunities to learn from one another and promote discussion of common areas of concern.   

The CDER Forum will be held in College Park, Maryland.  There is no registration fee for the program, however all attendees are responsible for their own travel and hotel expenses.

Please direct any questions to the CDER Forum mailbox: cderforum@fda.hhs.gov  

 

Registration Information

Registration information and requests should be sent to CDERForum@fda.hhs.gov. As a reminder, the CDER Forum is intended for international drug regulatory authorities, and registration from non drug regulatory authorities will not be honored.

Please include the following information about the proposed attendee:

  • Name
  • Position
  • Title
  • Country and Drug Regulatory Authority
  • Address
  • Phone
  • E-mail

  

For further information, contact:

Justina A. Molzon, MS Pharm, JD
Associate Director for International Programs
Center for Drug Evaluation and Research
United States Food and Drug Administration
U.S. Department of Health and Human Services
CDERForum@fda.hhs.gov