FDA Teleconference - May 23, 2011

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FDA Teleconference - May 23, 2011

The Food and Drug Administration (FDA) invites you to participate in a teleconference briefing to discuss two Direct Acting Antivirals (DAAs) for the treatment of hepatitis C, boceprevir and telaprevir, that were discussed at an April 27 -28, 2011 meeting of the FDA Antiviral Drugs Advisory Committee. DAAs represent a significant addition to the treatment approach for many patients. However, the dosing regimens may be complex, and there are treatment issues about which health care providers and patients should be aware.

The teleconference will be held on Monday, May 23, 2011 from 3:30 PM to 4:30 PM EDT. The toll-free number is 888-324-7513 . The passcode is FDA.

Following a brief introduction by Margaret Hamburg, Commissioner of the Food and Drug Administration, the briefing will provide an overview of the clinical trials, primary efficacy, safety, and complexity of dosing regimens. The briefing will consist of presentations by Debra Birnkrant, M.D, Director, and Jeffery Murray, Deputy Director, Division of Antiviral Products, Center for Drug Evaluation and Research (CDER), followed by an opportunity for questions from call participants. The briefing will be moderated by Richard Klein, FDA Office of Special Health Issues.

A replay will be available for 30 days, beginning approximately one hour after the briefing call ends. To hear the replay, callers can dial 888-324-7513.

Food and Drug Administration