Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products For Pre-Exposure Prophylaxis Guidance For Industry

This document was published by the U.S. Department of Health and Human Services on March 19, 2019. The purpose of the guidance is to provide sponsors non-clinical and clinical recommendations specific to the development of systemic drug products, with a focus on long-acting systemic drug products, regulated within the Center for Drug Evaluation and Research at the Food and Drug Administration for the prevention of sexually acquired human immunodeficiency virus-1 (HIV-1) infection . . .