Category Archives: FDA

  1. The FDA Evalutes the Decision on PrEP for HIV Prevention

    via The New York Times, Denis Grady An advisory panel to the Food and Drug Administration is expected to vote Thursday on whether a drug already used to treat H.I.V. infection should also be approved to prevent it. Such a recommendation, if made, would mark the first time that government advisers have advocated giving antiviral medicine to Read More >>

    drug development, drugs, FDA, hiv prevention, HIV/AIDS. pre-exposure prophylaxis, new prevention technologies, pre-exposure prophylaxis, PrEP, prevention, Truvada, USA
  2. We can’t afford to dismiss any new options in the quest to end AIDS

    Here is the letter from leading AIDS advocacy organizations sent to the FDA supporting a prevention indication for Truvada. IRMA is a co-signer,and supporter of these efforts. The FDA will be reviewing Gilead’s application for Truvada as PrEP on Thursday, May 10. Stay abreast of the developments on the PrEP Watch website. Click here for the FDA’s Read More >>

    FDA, Gilead, hiv prevention, new prevention technologies, pre-exposure prophylaxis, PrEP, Truvada
  3. Concerns about Gilead’s Truvada used as HIV Prevention

    via Financial Times, by Christine Livoti Gilead Sciences’ (NASDAQ: GILD) once-daily Truvada pill has seen only tepid interest for adoption in the HIV prevention setting, despite treatment guidelines by the Centers for Disease Control (CDC), experts told Biopharm Insight. This is largely related to issues around feasibility, cost and historical evidence for other prevention strategies, which may Read More >>

    FDA, Gilead, HPTN052, new prevention technologies, Treatment as Prevention, Truvada, United States
  4. Open Letter to FDA Urging Immediate PrEP Review

    via AIDS Foundation of Chicago This is an open letter to the Food and Drug Administration, urging the priority review of the drug Truvada for use in PrEP (pre-exposure prophylaxis). The AIDS Foundation of Chicago and 25 other organizations signed this letter to counter the AIDS Healthcare Foundation’s protest of the FDA regarding this review. To read Read More >>

    AIDS Foundation of Chicago, AVAC, FDA, Gilead, PrEP, Truvada
  5. Don’t Delay HIV Prevention for Gay and Bi Men

    via The Huffington Post, by David Ernesto Munar Lives will be saved when the Food and Drug Administration puts its stamp of approval on a groundbreaking preventative approach called pre-exposure prophylaxis, or PrEP, recently found to reduce HIV infections. With PrEP, people who are not infected with HIV take a daily pill, usually used to treat the Read More >>

    AIDS Foundation of Chicago, Bisexual, FDA, gay men, lgbt community, PrEP, transgendered, Treatment as Prevention, Truvada, United States
  6. HIV/AIDS Organizations Tell FDA and Gilead Sciences: Don’t Delay HIV Prevention for Gay and Bisexual Men and Transgender Women

    [Press Release – October 18, 2011] Thirteen prominent U.S. HIV/AIDS organizations have issued an open letter to the U.S. Food and Drug Administration and Gilead Sciences calling for prompt regulatory review of pre-exposure prophylaxis (PrEP) for HIV prevention in gay and bisexual men and transgender women (men who have sex with men, or MSM). The letter urges Read More >>

    FDA, gay men, Gilead, HIV/AIDS. pre-exposure prophylaxis, IRMA, new prevention technologies, PrEP, transgendered
  7. A Donor Deferred: The Lifetime Ban on Blood Donations from Gay Men

    via The Huffington Post, by Robert Valadez “Save a life, give blood,” read the sticker on a colleague’s lapel. It sounds wonderful — where do I sign up? Unfortunately, I can’t donate blood because I’m gay. Many people are surprised to hear that gay men are prohibited from donating blood in most countries around the world, including Read More >>

    blood ban, FDA, gay men, Gay Men's Health Crisis, HIV transmission, MSM, United States
  8. Pro/Con: Two views of U.S. prohibiting gay men’s blood donation

    via The Los Angeles Times, by Jessica Pauline Ogilvie Last month, the United Kingdom lifted its long-standing ban on accepting blood donations from gay men. Instead, health officials there implemented a new policy that allows men to become blood donors as long as they haven’t had sex with another man in the previous year. With this decision, Read More >>

    blood ban, FDA, gay men, MSM, United States
  9. AIDS Health Foundation (AHF) Questions Truvada’s Use as PrEP

    via Business Wire News Releases, by AIDS Healthcare Foundation AIDS Healthcare Foundation (AHF) unveiled a new print ad today that lays out data on the use of Gilead’s blockbuster HIV treatment drug Truvada as a pre-exposure prophylaxis (PrEP) or HIV prevention pill raising questions about the wisdom of pursuing approval by the U.S. Food & Drug Administration Read More >>

    Chicago, FDA, Gilead, lgbt community, Los Angeles, New York, PrEP, Truvada
  10. HIV Experts Create the Roadmap for Providing PrEP to Uninfected Individuals to Reduce the Risk of HIV Infection

    Press release via Forum for Collaborative HIV Research To stem the estimated 2.6 million new HIV infections that occur worldwide each year, more than 200 representatives from the scientific and HIV/AIDS communities took an important step in assessing the safety and public health implications of providing antiretroviral drugs to uninfected men and women exposed to HIV through Read More >>

    CDC, FDA, HIV/AIDS policy, new prevention technologies, pre-exposure prophylaxis, PrEP