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. FDA oversight Author(s): White, Robert S., author Publication: [Toronto, Ontario] : Thomson Reuters, 23-December-2019 Subject(s): Drug ApprovalDrug TherapyGovernment RegulationOrphan Drug ProductionRare Diseases -- drug therapyHumansUnited StatesUnited States. Food and Drug Administration.
