1. Assessing user fees under the Prescription Drug User Fee Amendments of 2017 Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018 Subject(s): Fees and ChargesInvestigational New Drug Application -- economicsPrescription Drugs -- economicsBiological Products -- economicsOrphan Drug Production -- economicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
2. Assessing user fees under the biosimilar user fee amendments of 2017 Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018 Subject(s): Biosimilar Pharmaceuticals -- economicsFees and ChargesInvestigational New Drug Application -- economicsDrug Evaluation -- economicsParenteral Nutrition Solutions -- economicsHumansUnited StatesUnited States. Department of Health and Human Services.United States. Food and Drug Administration.
