Dear Advocate,
Please join us for an upcoming webinar that’s designed as an advocates’ guide to the US Food and Drug Administration (FDA) review of data regarding TDF/FTC (Truvada) for HIV prevention. US-based advocates will be able to discuss steps for involvement in the process; international advocates may be interested in the topic as well, given that US FDA regulatory decisions are closely watched in many countries. The webinar will take place on Wednesday, February 29 at 3pm ET (for the time in your area, please visit www.timeanddate.com). [Apologies to our international partners for the late hour—we are planning to do additional calls on this topic area as other regulatory bodies are engaged.]
Please click here to register.
This past December, Gilead Sciences submitted a dossier to the FDA requesting a prevention indication for all adults for its drug TDF/FTC (Truvada). If this supplemental new drug application is approved, TDF/FTC will be the first antiretroviral approved for use as a prevention tool in HIV-negative people. On February 13, 2012, Gilead announced that the FDA granted priority review of its application. The upcoming webinar will feature resource people discussing FDA processes and, in particular, the role of community representatives on FDA review panels.
AVAC and partners, many of whom are part of an informal Ad Hoc PrEP Working Group, will be actively engaged in the FDA review process over the next four to five months. Shortly after next week’s webinar, a new document will be made available, “FDA’s Advisory Committee Review of Oral Pre-Exposure Prophylaxis (PrEP) to Prevent HIV Infection: An Advocate’s Primer for Public Participation”, a primer on of the steps involved and opportunities for participation.
The webinar will be recorded and published on the AVAC website, and we encourage anyone with questions in advance to forward them on to avac@avac.org. Many thanks for your interest, and we look forward to welcoming you on the webinar next week!
Best,
AVAC
