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Drug Approval

Reports

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ASPE Issue Brief

FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits

March 31, 2023
This issue brief provides a primer on FDA user fees, presents findings of how user fees affect the cost of medical product development, and summarizes the research literature on user fees, most notably in expediting medical product development and approval.
Report

Understanding Coverage Considerations for COVID-19 Vaccines and Treatments

August 31, 2022
COVID-19 vaccines and treatments have been an important tool in the prevention of COVID-19, including preventing hospitalizations and deaths.
Report

Cost of Generic Drug Development and Approval

February 3, 2022
The purpose of this study was to estimate the cost of generic drug development and approval. This study develops an analytical framework for examining the expected net present value (ENPV) (i.e., the difference between the present value of expected revenues over product life and cost of product development and approval) to a generic drug developer in different size drug markets.