12th CDER Forum for International Drug Regulatory Authorities (CDER Forum)

January 19, 2011

Dear International Colleague:

The Office of International Programs (OIP) and the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) would like to draw your attention to the 12th CDER Forum for International Drug Regulatory Authorities (CDER Forum) on April 4-8, 2011. FDA will host the CDER Forum in College Park, Maryland.

The semi-annual CDER Forum offers drug regulatory authorities the opportunity to learn about CDER Offices and speak with other regulators from around the world about drug oversight. The 12th CDER Forum will emphasize the drug review process. CDER technical review experts will discuss a review of etravirine (NDA 22-187), 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. The 12th CDER Forum will be interactive, providing participants with the opportunity to discuss common areas of concern and interest.

The CDER Forum is intended for international drug regulatory authorities only. As you and/or your colleagues consider potential participation, please note that it would be helpful for attendees to be actively involved in your government’s review process. There is no registration fee for the forum; however, all attendees are responsible for their own travel and hotel expenses.

For registration information and future updates, please visit: http://www.fda.gov/Drugs/NewsEvents/ucm239163.htm. Please direct any questions to the CDER Forum mailbox: CDERForum@fda.hhs.gov . I hope you will be able to join us.

Sincerely,

---/s/---

Mary Lou Valdez, MSM
Associate Commissioner for International Programs

Other International Outreach to Foreign Embassies