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Drug Development


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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.

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

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.