FDA Approval Expert Witnesses in Illinois
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Dr. James O' Donnell, PharmD, MS, RPh
Illinois
Dr. James O' Donnell has 52 years of experience in the field of Clinical Pharmacology. He earned his BS in Pharmacy from the University of Illinois Chicago, his PharmD from the University of Michigan, and then his MS in Clinical Nutrition from Rush University. He completed his residency in Hospital Pharmacy at the University of Illinois Hospital. Today, this expert is board certified in Clinical...
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Pharmacology and Toxicology Expert Witness
Illinois
This highly qualified Professor of Pharmacology received a bachelor's degree from the University of Illinois and went on to receive a doctorate in Pharmacy from the University of Michigan. He is board certified in Clinical Pharmacology and Nutrition. He is a Fellow of both the American College of Clinical Pharmacology and the American College of Nutrition. he has won many awards throughout his...
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Pharmacy Expert Witness
Illinois
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Washington
This licensed, WA pharmacist currently practices in the community setting at a large retail establishment. A member of the American Pharmacists Association, he has previously worked for commercial enterprises such as Walmart, Target, Walgreen's, and CVS, as well as in clinical environments such as St Luke's Episcopal Hospital in Texas. In addition to his current role as a pharmacy manager, he...
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Epidemiology Expert Witness
Illinois
This expert specializes in epidemiology, biostatistics and pharmacy. He is an alumnus of the UIC College of Pharmacy where he completed his PharmD before pursuing his MPH in Biostatistics and Epidemiology at New York University and a PhD in Epidemiology at the University of Washington. He completed additional training in cancer epidemiology and prevention as a postdoctoral fellow at the Fred...
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FDA Regulation of Medical Devices Expert Witness
Illinois
This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the...
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FDA Approval Expert Witness FAQs
An FDA Approval expert witness provides insight on regulatory compliance, drug approval processes, and medical device clearance. They can testify on whether proper procedures were followed.
Cases involving pharmaceuticals, medical devices, food safety, and cosmetics often require an FDA Approval expert witness. These experts are crucial in product liability or patent infringement cases.
In pharmaceutical litigation, an FDA Approval expert can provide testimony on drug development, clinical trials, labeling requirements, and post-market surveillance to establish if there was any negligence.
Yes, some experts specialize in specific areas like pharmaceuticals, medical devices, biologics, dietary supplements, or food products depending on their experience with FDA regulations.
Regulations and guidelines from the FDA frequently change. An expert with recent industry experience will have up-to-date knowledge about these changes and how they impact your case.
Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.