This landing page presents the abstract of a paper published in Health Affairs. The full text of the article is available at: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.2023.00837.
Drug Approval
Reports
Displaying 1 - 5 of 5. 10 per page. Page 1.
Advanced SearchResearch Summary
Costs of Drug Development and Research and Development Intensity in the US, 2000-2018
This landing page represents the abstract of a paper published in JAMA. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2820562.Abstract
Report
Understanding Coverage Considerations for COVID-19 Vaccines and Treatments
Understanding Coverage Considerations for COVID-19 Vaccines and Treatments (Updated May 2023)
ASPE Issue Brief
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
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
Cost of Generic Drug Development and Approval
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.