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Biomedical Innovation

Reports

Displaying 1 - 10 of 10. 10 per page. Page 1.

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ASPE Issue Brief

Understanding Markets for Antimicrobial Drugs

Development of novel antimicrobials has slowed, and the preclinical and clinical pipeline is likely to be insufficient to support current and future patient needs.
Report

Analysis of Market Challenges for Antimicrobial Drug Development in the United States

The market for antimicrobial (AM) drugs is unique in that it is associated with a positive externality (public health) as well as a negative externality (antimicrobial resistance, or AMR) (Mossialos, et al., 2010). AMR occurs when microbes change over time and no longer respond to available medicine.
Report

Antimicrobial Drugs - Market Returns Analysis

In 2017, at least 2.8 million people in the U.S. acquired serious infections with bacteria that are resistant to one or more antimicrobial drugs and 35,000 have died as a result. Resistance to antimicrobials is viewed as a global threat with antimicrobial drug use in human and animal health driving resistance.
ASPE Issue Brief

FDA User Fees: Examining Changes in Medical Product Development and Economic Benefits

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.
Report

Evaluating the Potential Impacts of Different Clinical Trial Strategies on Drug, Preventive Vaccine, and Therapeutic Complex Medical Device Development

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.

Personalized Health Care Expert Panel Meeting: Summary Report

Contents Demonstrating Clinical Validity and Utility Demonstrating Value Reducing Health Disparities Educating and Engaging Providers and Consumers Using Databases to Build Eviden

Health Care in Transition: Technology Assessment in the Private Sector

Health Care in Transition: Technology Assessment in the Private Sector Prepared by: Richard Rettig of the RAND Corporation Office of the Assistant Secretary of Planning and Evaluation Agency for Health Care Policy and Research. July, 1996.

Response of the Department of Health and Human Services to NBAC's Report 'Research Involving Human Biological Materials: Ethical Issues and Policy Guidance'

Cover letterHarold Shapiro, Ph.D., Chair National Bioethics Advisory Commission 6705 Rockledge Drive, Suite 700 MSC 7979 Bethesda, Maryland 20892-7979 Dear Dr. Shapiro: