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.
3. Generic drug user fees: application review times declined, but FDA should develop a plan for administering its unobligated user fees : report to the Chairman, Committee on Health, Education, Labor, and Pensions, U.S. Senate Publication: Washington, D.C. : U.S. Government Accountability Office, May 2017 Subject(s): Drugs, Generic -- economicsDrugs, Investigational -- economicsInvestigational New Drug Application -- economicsDrug Approval -- economicsHumansUnited StatesUnited States. Food and Drug Administration.