FDA Grand Rounds
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
Webcast
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]
Past Grand Rounds
2022
2021
- Closer to Zero
- The Development of Cellular-Level Structural and Functional Biomarkers of Eye Disease Enabled by Adaptive Optics
- Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to a Probable Carcinogen in Humans
- Immune System Responses to Therapeutic Proteins: Getting up close and personal
- SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern
- FDA's work with African Swine Fever from a policy and regulatory perspective
- Project Orbis: Global Collaborative Oncology Review Program
- Electrical Safety in CTP Regulated Products
- Studies of SARS-CoV-2 NSP1 and Envelope Protein
- Research and Development of Radioanalytical Capabilities for Detection of Radionuclides in Food
- FDA Grand Rounds: The CORE Network (or How I Learned to Love Lettuce…)
2020
- Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
- Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?
- Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
- Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
- Nanotechnology: Over a Decade of Progress and Innovation at FDA
- A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
- Artificial Intelligence for Regulatory Science Research
- Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
- Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
- Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
- Quality Control: Stopping infections before they happen through safer endoscope reprocessing
2019
- Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
- Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices
-
Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps
-
Uncertainty is the only certainty there is: Potential approaches for making public health decisions
2018
- Jerky Pet Treats and illness in dogs: a collaborative approach to investigating a mysterious outbreak
- Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
- The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
- Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
- How Simulation Can Transform Regulatory Pathways
- FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
- Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
- Ethnicity- and Gender-Related Differences in Alzheimer's Disease
2017
- Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
- Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
- Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
- Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
- Vaccine adjuvants: New ways to evaluate their safety and effectiveness
- Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products
2016
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