FDA Approval Expert Witnesses in Iowa

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FDA approval expert witnesses practice in a variety of fields, including regulatory affairs, clinical research, pharmaceuticals, and medical devices. Some of the most common specialties include FDA compliance, drug development, labeling, and post-market surveillance. They can opine on the effects of FDA regulations, approval pathways, safety standards, and enforcement actions on products and companies.

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  • 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 career including the American Society of Pharmacy Law honor for legal writing. He has published over 300 journal articles and book chapters and currently serves as a reviewingeditor of the American Journal of Therapeutics. He is frequently invited to lecture as a guest speaker both nationally and internationally. This expert is a former assistant director of pharmacy at Cook County Hospital, and is currently an associate professor of pharmacology at a major medical college.

    Associate Professor of Pharmacology, Major Medical College

    Master of Science (MS), Rush University

    Illinois

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  • Review Fee $400/hr
    Deposition Fee $450/hr

    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 Hutchinson Cancer Research Center in Seattle. His primary research interests are related to the influences of commonly used medications and comorbidity on cancer risk and outcomes among cancer survivors.

    Affiliate Investigator, A Cancer Research Center in IL

    Doctor of Philosophy (PhD), University of Washington

    Chicago,

    Illinois

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  • Review Fee $500/hr
    Deposition Fee $750/hr
    Court Fee $750/hr

    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 American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

    Consultant, A private consultancy for FDA regulated businesses in IL

    Bachelor of Arts (BA), California State University

    East Alton,

    Illinois

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What Can a FDA Approval Expert Witness Opine On?

Preclinical Testing

Assess safety and efficacy in labs.

Investigational New Drug Application

Submit data for human trial approval.

Phase 1 Clinical Trials

Test drug on a small group of subjects.

Phase 2 Clinical Trials

Evaluate effectiveness in larger patient groups.

Phase 3 Clinical Trials

Confirm effectiveness through extensive testing.

New Drug Application Submission

Request approval for market release.

FAQs for Fda Approval Expert Witnesses

What is a fda approval expert witness?

An FDA approval expert witness is a specialist who explains FDA rules and drug or device approval processes in legal cases. They assist by reviewing records, offering opinions, and testifying to clarify FDA compliance issues.

What types of cases may benefit from the insights of an FDA Approval expert witness?

An FDA approval expert witness supports drug, device, biologic, clinical trial, labeling, marketing, compliance, and product liability cases involving FDA regulatory standards.

How can an FDA Approval expert witness evaluate regulatory compliance timelines?

An FDA approval expert witness evaluates regulatory compliance timelines by comparing documented development, submission, and review milestones against FDA guidance and statutory deadlines.

What qualifications should an FDA Approval expert witness possess for complex litigation?

An FDA approval expert witness should have advanced scientific or medical training, regulatory experience, and a proven track record with FDA approval processes and complex litigation.

How does an FDA Approval expert witness assess adequacy of premarket submissions?

An FDA approval expert witness assesses adequacy of premarket submissions by comparing study design, data quality, and labeling to current FDA regulations, guidance, and review standards.

What is Expert Institute’s process for selecting fda approval expert witnesses?

Expert Institute delivers a tailored approach to connect you with top-tier experts. We identify actively practicing professionals who meet your exact criteria for specialty, experience, litigation background, fee structure, credentials, location, and more.

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