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The Food and Drug Administration (FDA) has issued new guidance intended to assist sponsors in the clinical development of drugs for the treatment of HIV infection. Specifically, it addresses the FDA’s current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products.

New guidance assists HIV drug development

January 1, 2003

The Food and Drug Administration (FDA) has issued new guidance intended to assist sponsors in the clinical development of drugs for the treatment of HIV infection. Specifically, it addresses the FDAs current thinking regarding designs of clinical trials that use HIV ribonucleic acid (RNA) measurements to support accelerated and traditional approvals of antiretroviral drug products.