IDSA Press Release: Passage of PEPFAR Stewardship Act
WASHINGTON, DC – The U.S. Senate’s unanimous and decisive passage Monday night of legislation extending the President’s Emergency Plan For AIDS Relief for five more years gives hope to millions of people around the world still in need of services to prevent and treat HIV, renews a commitment to the most ambitious and effective health response this country has undertaken, and acknowledges the importance of this historic program to the American people. Click here to read the full press release from the IDSA Center for Global Health Policy and HIVMA.
Viral Hepatitis Action Plan - 2012 Highlights of Federal Efforts
The HHS Office of HIV/AIDS and Infectious Disease Policy (OHAIDP) has shared a new report that features 2012 highlights of federal efforts to implement the Action Plan for the Prevention, Care and Treatment of Viral Hepatitis.
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Revised FDA Draft Guidance on Clinical Development of Treatment for Chronic Hepatitis C
The Food and Drug Administration has published draft guidance to assist sponsors in the clinical development of direct-acting antiviral drugs for the treatment of chronic hepatitis C from the initial pre-investigational new drug application (pre-IND) through the new drug application and postmarketing stages.
Click here to read the draft guidance.
FDA Approves Dolutegravir to Treat HIV Infection
The U.S. Food and Drug Administration approved dolutegravir, a new integrase inhibitor to treat HIV-1 infection. Dolutegravir, taken in combination with other antiretroviral drugs, is approved for use in treatment-naive and treatment-experienced adults and children ages 12 and older.
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FDA Approves First Rapid Test to Detect HIV-1 Antigen and HIV-1/2 Antibodies
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International Guidelines for Prevention and Treatment of HCV Among People Who Inject Drugs Released
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Dr. Stefano Bertozzi Named New Dean of UC Berkeley School of Public Health
The Forum congratulates Dr. Stefano Bertozzi who has been named dean of the University of California, Berkeley School of Public Health, effective September 1, 2013. The Forum has had the honor of working with Dr. Bertozzi in his current position at eh Bill and Melinda Gates Foundation. We welcome him to UC Berkeley and look forward to working with him in his new role as dean.
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Dr. Jonathan Mermin named Director of CDC NCHHSTP
Jonathan "Jono" Mermin, MD, MPH, has been appointed as the new director of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) at the Centers for Disease Control and Prevention (CDC). He will begin his tenure on July 25. -
Click here to read the full story at blog.AIDS.gov
New FDA Guidance for Industry - HIV1: Developing Antiretroviral Drugs for Treatment
New FDA guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA's Center for Drug Evaluation and Research (CDER) for the treatment of HIV-1 infection. Specifically, this guidance addresses the overall development program and clinical trial designs for antiretroviral drugs to support an indication for the treatment of HIV-1 infection.
View the Guidance >>
FDA Approves First Genotyping Assay for HCV
The FDA has approved the Abbott RealTime HCV Genotype II, an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay intended for use as an aid in the management of HCV-infected individuals and in guiding the selection of therapeutic treatment indicated for the above listed genotypes in patients who are chronically infected with HCV who are being considered for antiviral treatment, and are positive for HCV RNA.
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