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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Risk Assessment Research: Development of Tools that Evaluate and Enhance the Safety of Biologic Products

Principal Investigator: Steve Anderson, PhD
Office / Division: OBE / IO


Public Health Issue: Risks are associated with biologic products - examples include prions in blood products, smallpox vaccine, insufficient supply of a product, or adverse events in gene therapies. Risks can emerge during pre-market phases, post-market, or during an event that necessitates its use. Unfortunately, there may be only limited information available to formally estimate these risks and identify risk reduction strategies.

Regulatory Contribution: Risk assessments are often used when data are limited or absent. It is a tool that can inform the science-based decision-making processes and identify optimal risk reduction policies. Risk assessment identifies critical data gaps and thus, can be used to determine research priorities that will provide information to reduce uncertainty and improve the predictions of risk.

Research Approach: The focus of our work is the development of risk assessments and methods that estimate the magnitude of risk and evaluate possible risk reduction strategies. This program develops risk assessments, which consist of a computer model and a document detailing the model, assumptions, equations, results and conclusions. The models are used to evaluate various risk management and the most optimal risk management approaches. Ongoing risk assessment activities focus on variant Creutzfeldt-Jakob disease (vCJD) risks for blood plasma-derived products, estimation of U.S. blood utilization and supply, and stem cell and gene therapy.

Mission Relevance and Outcomes: The risk assessments we generate provide estimates of risk, and identify potential risk reduction strategies, data gaps and research priorities. This improved information can be used by FDA staff, advisory committees, and regulated industry to support regulatory processes that manage and reduce risks for biologic products. Risk assessment also provides the science-based foundation for more effective risk communication efforts.


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002