FDA Approval Expert Witnesses

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FDA approval expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, food safety, biotechnology, and clinical trials. Some of the most common FDA approval expert witness specialties also include drug labeling, dietary supplements, cosmetic products, veterinary medicine, and tobacco products. They can opine on the effects of regulatory compliance, product recalls, adverse event reporting, post-market surveillance, and risk management.

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Adam Marc Kaye, PharmD, RPhView profile

ID: 108670

Dr. Adam Marc Kaye, PharmD, RPh

Dr. Adam M. Kaye has 30 years of experience in the field of Pharmacy. He earned his AS from Pima Community College and his PharmD from the Thomas J. Long School of Pharmacy. Today, this expert is licensed as a Registered Pharmacist in Arizona and California. Formerly, this expert held roles as Pharmaceutical Consultant I for the California Department of Health Care Services and as a Pharmacist...

Forensic Toxicology and Pharmacology Expert Witness | ColoradoView profile

E-702886

Forensic Toxicology and Pharmacology Expert Witness | Colorado

This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association....

Ken L SaundersView profile

ID: 25599

Dr. Ken L Saunders

This highly-qualified expert has nearly 35 years of experience in hospital pharmacy operations. He earned his PharmD from the University of Nebraska Medical Center and is licensed as a registered pharmacist. He is active in his field as a member of numerous professional societies, including serving as vice chairman and chairman of both the Nebraska Board of Pharmacy and the Nebraska Medicaid...

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Pediatric & Adult Clinical Pharmacology and Toxicology Expert Witness | OhioView profile

E-702455

Pediatric & Adult Clinical Pharmacology and Toxicology Expert Witness | Ohio

This highly-qualified expert has nearly 45 years of experience in pharmacology. He specializes in pediatric clinical pharmacology, toxicology, and clinical pharmacy, as well as adverse drug reactions, drug-drug-food interactions, pharmacokinetics-pharmacodynamics, and pharmacogenomics. He earned both his BS in pharmacy and his PharmD from the University of Cincinnati. He also completed an...

Onyema A EzeanyaView profile

ID: 26028

Dr. Onyema A Ezeanya

This highly-qualified expert has nearly 15 years of experience as a pharmacist. He earned his PharmD from Florida Agricultural and Mechanical University and his MS in pharmaceutical regulations from the University of Florida. He also completed a residency in pharmacy practice at Tampa General Hospital. This expert is a board-certified pharmacotherapy specialist and also holds certifications in...

Pharmacology Expert Witness | New YorkView profile

E-570667

Pharmacology Expert Witness | New York

This highly-qualified expert has over 30 years of experience in pharmacology. He earned his BS in pharmacy from Albany College of Pharmacy before earning his PhD from Shenandoah University. He is a board-certified pharmacotherapy specialist and a licensed pharmacist. He also holds a certification in pediatric advanced life support. He is active in his field as an author of several scientific...

Natalie HalanskiView profile

ID: 41936

Dr. Natalie Halanski

This expert earned her BS and PharmD at the Univesity of Michigan and she completed her residency in ambulatory care pharmacy at the University of San Diego. She is a board-certified ambulatory care pharmacist and a member of the American Pharmacists Association. She formally worked as a clinical pharmacist in ambulatory care at the University of California, San Diego and she currently is a...

Internal Medicine Expert Witness # E-000369View profile

E-000369

Internal Medicine Expert Witness # E-000369

This expert is a board certified internal medicine doctor who has been working as an attending physician in a nursing home for over 30 years. He has extensive experience in dealing with patients who are at higher risk for falls.

William Walton Stoops, PhDView profile

ID: 54182

Dr. William Walton Stoops, PhD

Dr. William W. Stoops has over 15 years of experience in the field of Behavioral Psychopharmacology. He earned his BA in Psychology from Davidson College, and his MA and Ph.D. in Experimental Psychology from the University of Kentucky. Formerly, this expert served as an Associate Professor of Psychiatry at University of Kentucky College of Medicine, as an Associate Professor of Psychology at the...

Toxicology Expert Witness | PennsylvaniaView profile

E-001445

Toxicology Expert Witness | Pennsylvania

This expert holds a doctorate degree in toxicology and has been a practicing toxicologist for over 40 years. Board certified by the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, he had published over 35 scientific articles and is a former president of the Mid-Atlantic chapter of the Society of Toxicology. He spent over 30 years as a Director of Toxicology for...

Dipak Panigrahy, MDView profile

ID: 96548

Dr. Dipak Panigrahy, MD

Dr. Dipak Panigraphy has over 20 years of experience in Cancer Biology Research. He earned his BA from Boston University and his MD from Boston University School of Medicine. After completing his residency in Surgery at Rutgers Robert Wood Johnson Medical School, he went on to complete a research fellowship in Vascular Biology at Boston Children's Hospital. Formerly, this expert held roles as an...

Food and Drug Expert Witness | New YorkView profile

E-004870

Food and Drug Expert Witness | New York

This qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

James Thomas O’ Donnell III, MS, PharmD, RPhView profile

ID: 116818

Dr. James Thomas O’ Donnell III, MS, PharmD, RPh

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...

Pharmacy Expert Witness | North CarolinaView profile

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Pharmacy Expert Witness | North Carolina

This certified compounding pharmacist has received his training from a top pharmacy program and holds clinical and academic positions in his field at both pharmacy and medical schools. He has given invited lectures on compounding pharmacy, and has authored major publications on the topic. Furthermore, he has been in practice since 1977 and has owned a compounding-only pharmacy since 2003. He...

David Henry Eagerton, FABFT, PhDView profile

ID: 121136

Dr. David Henry Eagerton, FABFT, PhD

Dr. David H. Eagerton has over 36 years of experience in Pharmacology and Toxicology. He earned his BS in Biology from the University of South Carolina, and his Ph.D. in Pharmacology from the University of South Carolina College of Pharmacy. Today, this expert is a Fellow of the American Board of Forensic Toxicology. Formerly, this expert held roles as the Executive Director of the Campbell...

Drug Safety & Pharmacoepidemiology Expert Witness | AlabamaView profile

E-007175

Drug Safety & Pharmacoepidemiology Expert Witness | Alabama

This expert isProfessor and Head of the Department of Health Outcomes Research and Policy at a major university school of pharmacy. He holds a bachelors degree in pharmacy from the University of Wisconsin, and a PhD in Social, Administrative, and Clinical Pharmacy from the University of Minnesota. Prior to joining Auburn University he was Associate Professor of Pharmaceutical Outcomes and...

Mark L Westerman, MBAView profile

ID: 126753

Mr. Mark L Westerman, MBA

Mr. Mark Westerman has over 20 years of experience in Project Management and Compliance for the Pharmaceutical, Biotechnology, and Insurance industries. He earned his AA in Business Transfer Studies from Polk State College, BA in Business Administration and Management from the University of Central Florida, and MBA from Indiana State University. Today, this expert is Scrum Master Certified as...

Neurology Expert Witness | NevadaView profile

E-007502

Neurology Expert Witness | Nevada

This board-certified and fellowship-trained expert has over 20 years of experience in neurology with extensive clinical research experience, contributing to over 55 different clinical studies. He has involved in various committees for the University of Nevada School of Medicine. He currently serves as Associate Professor of Neurology and Medical Director for an ALS and muscular dystrophy clinic.

David Lane Eaton, PhDView profile

ID: 129665

Dr. David Lane Eaton, PhD

Dr. David L. Eaton has over 43 years of experience in the field of Toxicology.. He earned his BS in Pre-Medicine from Montana State University and his Ph.D. in Pharmacology from the University of Kansas Medical Center. He completed his Predoctoral Training in Pharmacology and his Postdoctoral Training in Toxicology at the University of Kansas Medical Center.Formerly, he served as the Director and...

Chemical Analysis Expert Witness | MichiganView profile

E-007665

Chemical Analysis Expert Witness | Michigan

This expert has over 25 years of experience in analytical chemistry including pharmaceutical development. With a Ph.D. from the prestigious Massachusetts Institute of Technology, he has published in analytical and physical chemistry. His previous positions include various lead positions of research and development as well as analytical testing. He currently serves as a Senior Vice President of an...

FDA Approval Posts

FDA Approval Expert Witness FAQs

What is the role of an FDA Approval expert witness in a legal case?

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.

What types of cases might require an FDA Approval expert witness?

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.

How can an FDA Approval expert witness assist in a pharmaceutical litigation case?

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.

Are there subspecialties within the field of FDA Approval for expert witnesses?

Yes, some experts specialize in specific areas like pharmaceuticals, medical devices, biologics, dietary supplements, or food products depending on their experience with FDA regulations.

Why is it important to hire an FDA Approval expert witness with recent industry experience?

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.

How does Expert Institute select its FDA Approval expert witnesses?

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.

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