March-in authority allows the federal government to grant licenses on privately owned patents for inventions developed with federal funding provided certain statutory requirements are met. It was designed to ensure that the benefits of the American taxpayers’ investment in research and development are reasonably accessible to the public.
Biomedical Research Policy
Reports
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Advanced SearchASPE Issue Brief
An Examination of March-in Rights and Drug Products with Government-Interest Patents
ASPE Issue Brief
Participant Diversity by Race, Ethnicity, and Sex in Rare Disease Clinical Trials: A Case Study of Eight Rare Cancers
Rare cancer clinical trials appear to enroll less diverse participants than clinical trials more broadly and therefore may require additional considerations or unique solutions to diversify participant recruitment. These differences persisted within both NIH and non-NIH funded trials.
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.
Therapeutic Complex Medical Device Development
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.
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
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: