FDA Announces Final Guidance: HIV-1 Infection: Developing Antiretroviral Drugs for Treatment: Guidance for Industry

FDA is announcing final guidance titled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment: Guidance for Industry.”   This guidance provides recommendations for the development of antiretroviral drugs regulated within the Center for Drug Evaluation and Research at the FDA for the treatment of human immunodeficiency virus-1 (HIV-1 or HIV) infection. Specifically, this 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 guidance is available at: http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm355128.pdf