HIV/AIDS Update - Final Guidance: HIV-1 Infection: Developing Antiretroviral Drugs for Treatment

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: HIV/AIDS Update - Final Guidance: HIV-1 Infection: Developing Antiretroviral Drugs for Treatment

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Information about FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.

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FDA is announcing final guidance titled: Human Immunodeficiency Virus-1 Infection:  Developing Antiretroviral Drugs for Treatment. This guidance finalizes and replaces the draft guidance of the same name (issued June 2013) and replaces the final guidance Antiretroviral Drugs Using Plasma HIV-RNA Measurements — Clinical Considerations for Accelerated and Traditional Approval (issued October 2002).

The guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA Center for Drug Evaluation and Research for the treatment of human immunodeficiency virus-1 (HIV-1 or HIV) infection. Specifically, the guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs for antiretroviral drugs to support an indication for the treatment of HIV-1 infection. The organization of the guidance parallels the development plan for a particular drug or biologic.

It does not address the use of antiretroviral drugs for preventing transmission of HIV-1 infection.

The final guidance is available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

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