1. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases Publication: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018 Subject(s): Drug ApprovalOrphan Drug ProductionPediatricsAdolescentBiological ProductsChildClinical Trials as TopicColitis, Ulcerative -- drug therapyHIV Infections -- drug therapyInfantPrevalenceHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Pediatric HIV infection: drug product development for treatment Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019 Subject(s): Drug Development -- standardsHIV Infections -- drug therapyPediatricsAdolescentAnti-Retroviral Agents -- therapeutic useChildClinical Trials as TopicHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
3. 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.
