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.
Biomedical Research & Development
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ASPE Issue Brief
FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
March 31, 2023
Therapeutic Complex Medical Device Development
November 4, 2022
This report quantified the potential impacts of select clinical strategies on the cost, duration, and phase transition probability associated with therapeutic complex medical device development stages. The model used data from a variety of sources (public and non-public) and widely accepted economic methods.
Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development
November 4, 2022
This environmental scan, conducted from September 2016 – September 2021, examines the potential impacts of select strategies on the cost, duration, and phase transition probability associated with drug, preventive vaccine, and therapeutic complex medical device development stages.
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes
September 29, 2021
The objective of this report is to assess the current landscape of federal and federally funded health care data relevant to PCOR and economic analysis to identify gaps for data stewards, researchers, and future collection efforts.
Cost Drivers in the Development and Validation of Biomarkers Used in Drug Development
October 23, 2018
Despite the increasing investment and interest in drug development, the amount of time and resources needed to develop a new drug continues to rise. Biomarkers are an important tool with the potential to decrease the time, cost, and failure rate of drug development.
Personalized Health Care Expert Panel Meeting: Summary Report
September 9, 2007
Contents Demonstrating Clinical Validity and Utility Demonstrating Value Reducing Health Disparities Educating and Engaging Providers and Consumers Using Databases to Build Eviden