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Medical Product Development

Reports

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National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Year 4

February 13, 2020
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.
ASPE Data Point

Current Estimates of Supply and Utilization of Immune Globulin Products

May 12, 2019
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

Economic Incentives for the Development of Rapid Point-of-Care (POC) Diagnostic Devices for C.Difficile, Carbapenem-Resistant Enterobacteriaceae (CRE), and Neisseria Gonorrhoeae

January 1, 2019
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.

National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report: Year 3

November 12, 2018
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.

National Action Plan for Combating Antibiotic-Resistant Bacteria Progress Report for Years 1 and 2

November 12, 2017
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.

Analysis Report: Understanding the Role of Partnerships in Medical Product Development

July 26, 2017
Partnerships involving public sector organizations, academia, non-profits, and pharmaceutical companies have demonstrated their potential for addressing unmet needs in medical product research and development (R&D). Effective partnerships can enhance access to innovation, reduce risk, manage costs, and may provide a means for steering R&D investment to address societal objectives.

Examination of Clinical Trial Costs and Barriers for Drug Development

July 24, 2014
Pharmaceutical companies conduct clinical trials for many reasons. The most obvious goal of clinical trials is to demonstrate safety and efficacy to gain Food and Drug Administration (FDA) approval. FDA provides guidance to developers about what constitutes acceptable clinical trials and appropriate outcomes.

Analytical Framework for Examining the Value of Antibacterial Products

April 14, 2014
Antibacterial resistance is a growing global problem. At least 2 million people in the U.S. acquire serious infections with bacteria that are resistant to one or more of antibacterial drugs designed to treat it.

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.

Economic Analysis of Availability of Follow-on Protein Products

July 26, 2009
Contract HHSP23320045017XI Task Order HHSP233200700003T Prepared for: Department of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation Prepared by: