1. Prescription Drug User Fee Act waivers, reductions, and refunds for drug and biological products Publication: Silver Spring, MD : Center for Drug Evaluation and Research, October 2019 Subject(s): Drug Approval -- economicsDrug Approval -- legislation & jurisprudenceInvestigational New Drug Application -- legislation & jurisprudenceDiffusion of InnovationEconomics, PharmaceuticalOrphan Drug Production -- economicsPublic HealthSmall BusinessHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.United States.