Medical Product Development

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.

Shortages of critical medical devices during the COVID-19 pandemic exposed vulnerabilities in device markets. From 2010 to 2019 there were approximately five shortages annually, but that number increased fourfold in the first half of 2020.

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.

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.

This document presents the abstract of this paper, as published in JAMA Network Open. The full text of the article is available at: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2796179 Related Products:

Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.

In February 2007, the Eastern Research Group (ERG) submitted to the Office of the Assistant Secretary for Planning and Evaluation (ASPE) Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous (IG

Antibacterial resistance is responsible for excess morbidity, mortality, and medical costs around the globe. Estimates vary widely, but the economic cost of antibacterial resistance in the United States could be as high as $20 billion and $35 billion a year in excess direct healthcare costs and lost productivity costs, respectively. CDC’s most recent report on U.S.

Antibiotic Resistance continues to pose a significant threat to our Nation’s public health. To coordinate and enhance the public health response to this threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, USDA, and DOD.

Antibiotic resistance (AR) poses a significant threat to our Nation’s public health. To coordinate and enhance the public health response to the AR threat, the U.S. Government developed the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB). The CARB Task Force is co-chaired by HHS, the U.S. Department of Agriculture, and the U.S. Department of Defense.