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FDA guidance for industry HIV development and trials

The US FDA have published new draft Guidance for Industry: Antiretroviral Drugs Using Plasma HIV-RNA Measurements – Clinical Considerations for Accelerated and Traditional Approval.

The new 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. 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.

Source: FDA list serve. Draft Guidance for Industry: Antiretroviral Drugs Using Plasma HIV-RNA Measurements – Clinical Considerations for Accelerated and Traditional Approval. (10 June 2013).

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070968.pdf?source=govdelivery

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