FDA Issues Final Industry Guidance for Developing Antiretroviral Drugs for HIV Treatment


This week, FDA announced the availability of a final guidance [PDF 610 KB] for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.” The guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA Center for Drug Evaluation and Research for the treatment of HIV infection. This guidance assists sponsors in…

FDA approves new treatment for HIV


The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. The CDC estimates that 1.2 million persons ages 13 years and older are living…

HHS World Hepatitis Day Observance Showcased Progress & Collaboration


On July 28, the U.S. Department of Health and Human Services (HHS) hosted the fifth annual observance of World Hepatitis Day to continue raising awareness of the burden of viral hepatitis both here in the U.S. and around the world. Globally, viral hepatitis affects 400 million people and kills over 1.4 million people annually , and…

FDA Invites Comments on Proposal to Revise Lifetime Deferral on Blood Donation by Gay Men


In a Federal Register notice published Friday, May 15, 2015, the Food and Drug Administration (FDA) is inviting public comments on the following draft recommendations: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products [PDF 135KB]. This draft guidance, to establishments that collect blood or blood components, proposes…

2014 Viral Hepatitis Year-in-Review and Looking to 2015

Ronald Valdiserri

2014 has been a year of both opportunities and challenges in the fight against viral hepatitis. In May, the World Health Assembly passed a new resolution  [PDF 151 KB] on viral hepatitis, urging member states to develop and implement coordinated, national strategies for preventing, diagnosing and treating viral hepatitis.  Our nation’s own comprehensive viral hepatitis strategy,…

FDA Commissioner Margaret A. Hamburg’s statement on FDA’s blood donor deferral policy for men who have sex with men


The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsibility to regulate the blood supply and to help ensure its continued safety for the patients who receive these life-saving products. Over the past several years, in collaboration with…

FDA approves Viekira Pak to treat hepatitis C


The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that…

For an AIDS-Free Generation: Access to Drugs and Diagnostics Is Essential


On World AIDS Day this year, tens of millions of people with HIV are now living healthy, productive lives because of access to safe and lower priced medicines. We rejoice in this achievement, because all people, no matter how rich or poor, deserve to have the medicines they need to live their lives in the…