1. Human immunodeficiency virus-1 infection: developing systemic drug products for pre-exposure prophylaxis Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019 Subject(s): Drug DevelopmentHIV Infections -- prevention & controlPre-Exposure ProphylaxisAdolescentChildClinical Trials as TopicHIV Infections -- drug therapyHIV-1InfantHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.