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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 4-8, 2011, 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 4-8, 2011. In the past, CDER Forums provided an overview of CDER Offices. Recent CDER Forums have placed 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 to be discussed at the 12th CDER Forum is etravirine (NDA 22-187).

Etravirine is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to an NNRTI and other antiretroviral agents.

Etravirine will serve as a platform to discuss CDER's review process. In addition, case studies of other submissions will address difficult review issues, and a special presentation on regulatory considerations for microbicide development will be provided. Because 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