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.
Drug Development
Reports
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FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits
March 31, 2023
Prescription Drug Pricing: ASPE Resources Related to Safe Harbor Rule
January 31, 2019
Department of Health and Human Services Secretary Alex Azar and Inspector General Daniel Levinson have issued a proposed rule, “Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in
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.
Health Care Cost Containment and Medical Innovation
July 22, 2012
ASPE ISSUE BRIEF Health Care Cost Containment and Medical Innovation May 2012 By: Amber Jessup, Ph.D.
Expanding the Use of Generic Drugs
November 30, 2010
ASPE ISSUE BRIEF Expanding the Use of Generic Drugs By: ASPE Staff December 1, 2010
Medicaid Contracts with Medicare Special Needs Plans Reflect Diverse State Approaches to Dually Eligible Beneficiaries
October 31, 2009
U.S. Department of Health and Human Services
Prescription Drug Spending by Medicare Beneficiaries in Institutional and Residential Settings, 1998-2001
May 31, 2007
U.S. Department of Health and Human Services
Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IGIV)
January 31, 2007
Contents IGIV Supply and Distribution - Key Findings IGIV Demand - Key Fundings IGIV Access Problems- Key Fundings Immune globulin intravenous (IGIV), also referred to as intravenous immune globulin (IVIG), is a valuable treatment for many seriously ill patients. Although the U.S.
Cost Effectiveness Considerations in the Approval and Adoption of New Health Technologies
December 31, 2006
Contents Background and Purpose Methodology Summary of Key Findings and Stakeholder Suggestions Conclusions and Policy Implications A.