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.
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- Therapeutic Complex Medical Device Development
- Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development
- Estimated Cost of Developing a Therapeutic Complex Medical Device in the US
- Cost of Generic Drug Development and Approval