James E Polli
University of Maryland, Baltimore, MD·Pharmacology
Before a drug, device or food product reaches the public, regulators must judge whether it is safe, effective and of consistent quality — and the tests and standards used to make that judgment are themselves a subject of research. That field, regulatory science, develops the tools, standards and approaches used to assess products the U.S.
- Fields
Pharmacology
Medicine & Clinical Research
Public Health & Epidemiology
- Topics
regulatory science
drug development
post-market surveillance
- Grants
- 1 known grant, through Aug 2027
What they work on
- Conduct regulatory science research jointly with FDA scientists on modernizing the development and evaluation of FDA-regulated products, drawing on biomedical, health outcomes and engineering capabilities across two University of Maryland campuses.
- Strengthen post-market surveillance and labeling of FDA-regulated products through collaborative projects aligned with the FDA's regulatory science framework.
- Build Center infrastructure and a Research Scientist Collaboration Program that creates mechanisms for new University of Maryland–FDA research partnerships.
- Expand regulatory science information sharing through workshops, lectures, a scholars program and the America's Got Regulatory Science Talent Competition, and increase access for faculty, FDA scientists and trainees underrepresented in the field.
More about the research
Food and Drug Administration (FDA) regulates. Improving those methods matters because outdated or inadequate tests can slow useful products or miss problems after products reach the market.
Why it matters
The methods regulators use to judge safety, efficacy, quality and performance determine how quickly sound medical products reach patients and how reliably problems are caught once products are in use. Research conducted jointly with FDA scientists could modernize those evaluation tools, improve post-market surveillance and labeling, and strengthen public health preparedness, while training a workforce able to do this work.
Known grants
From NIH and NSF research grants. Labs often have other funding we can't see.
Closest labs
Meghan Morean
Yale University, CT·Public Health & Epidemiology
Refine an ENDS nicotine concentration label so its strength categories are anchored to cigarette nicotine content, using expert feedback and focus groups.
Alex Liber
University of Michigan, MI·Public Health & Epidemiology
Analyze how tobacco regulatory policies perform once implemented, using detailed comparative case studies and policy surveillance that tracks the laws in force across jurisdictions.
Jihyoun Jeon
University of Michigan, MI·Public Health & Epidemiology
Provide uniform data processing and analysis services across the Center's four research projects, pilot projects, and the wider TCORS Consortium so that results are produced to consistent standards.
The school
University of Maryland, Baltimore: 23 labs on PI Pages, $1.5B a year on research, 79 research doctorates a year.
Reach out
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