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The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

Challenges in Predicting the Environmental Exposure Concentration of Terrestrial Animal Drugs

February, February 10, 2022
12:00 p.m. - 1:00 p.m. EST

About the Speaker

Andrew N. Miglino, Ph.D.
Physical Scientist
Environmental Team 2
Division of Scientific Support (DSS)
Office of New Animal Drug Evaluation (ONADE)
Center for Veterinary Medicine (CVM)
U.S. Food and Drug Administration (FDA)

Dr. Andrew Miglino is a physical scientist on the FDA Center for Veterinary Medicine’s Environmental Team. Dr. Miglino has conducted environmental reviews of difficult to test substances, steroid hormones, and aquaculture drugs among other veterinary medical products, and is the primary developer of a computer model that estimates concentrations of animal drugs in the soil and water environment, known as VETPEC. Dr. Miglino received his Ph.D. in Environmental Engineering from the University of Delaware and specializes in environmental fate modeling.

About the Presentation

As part of the environmental review process under the National Environmental Policy Act (NEPA), the Center for Veterinary Medicine (CVM) determines the exposure concentration for proposed new animal drugs in the environment. Due to the complexity of estimating these concentrations for the various environmental conditions in the United States, CVM has developed an environmental fate model, VETPEC, which uses animal characteristics, spatially and temporally variable data, and modern scientific principles to calculate daily environmental concentrations of animal drugs. This seminar will highlight CVM's environmental review process with a focus on the exposure assessment.

For technical assistance please contact: [email protected]

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