FDA Approval Expert Witnesses in New York
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Dr. David Jacobs
New York
This highly qualified expert earned his BS in chemistry from Binghamton University and his MD from the University at Buffalo. After completing his residency in pharmacy, this expert went on to complete a prestigious fellowship in Pharmacoepidemiology at the University at Buffalo. He is also active in his field as a member of numerous medical societies including the American College of Clinical...
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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...
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Mr. Kevin Christopher Durand
New York
This qualified expert has over 20 of experience years in the field of medical devices with an expertise in injectable drug technologies. Throughout his career, this expert has been employed by and consulted with multiple medical device and pharmaceutical companies and has gained significant experience in technological analysis, medical device engineering and manufacturing, product compliance, and...
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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.
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Ms. Judy Ganes
New York
This highly-qualified expert has over 30 years of experience as a market analyst and consultant specializing in the coffee industry. She earned her BS in marketing and management at SUNY Albany and is an active member and past president of the Internation Women's Coffee Alliance. In addition, she is a member of the Specialty Coffee Association of America and the ICE Research Program. This expert...
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Pharmaceutical Sciences and Clinical Pharmacology Expert Witness
New York
This highly qualified Professor of Pharmaceutical Sciences received a bachelors in Pharmacy and a PharmD in Clinical Pharmacy. He is a member of numerous highly regarded professional organizations including the American Association of Pharmaceutical Scientists and the American College of Clinical Pharmacology. He is an innovator with 10 patents registered in his name. He is widely published in...
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Internal Medicine and Clinical Pharmacology Expert Witness
New York
This expert began his career as a medical consultant to the emergency room drug treatment and referral program. He’s been practicing for over 40 years and focuses on internal medicine, consulting in clinical pharmacology, and quality assurance medicine. He is currently involved in many aspects of pharmacology, and holds many positions on boards and committees related to drug abuse, prevention,...
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Pharmacy Regulations Expert Witness
New York
This extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the...
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Pharmaceuticals and Transdermal & Topical Drug Delivery Expert Witness
New York
This highly-qualified expert has extensive experience with pharmaceutical formulation development, as well as transdermal, topical, and controlled release drug delivery. He earned his BS in pharmaceutical science from Sandar Patel University before earning his MS and PhD in pharmaceutical science from Long Island University. This expert is active in his field as a member of the American...
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Clinical Pharmacology & Toxicology Expert Witness
New York
This highly qualified expert has been conducting academic studies in toxicology for 30+ years. He completed his postdoctoral and fellowship training at Rochester University. He is a fellow at the American Association for the Advancement of the Sciences and a member of numerous professional associations, including the Academy of Toxicological Sciences, where he serves in the board of directors. He...
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Product Formulation Patent Infringement Expert Witness
New York
This well-credentialed expert earned his B.S. in Pharmacy from Columbia University, an M.S. in Pharmacy from the University of Iowa, and a Ph.D. in Pharmaceutical Chemistry from the University of Iowa. He has extensive experience in cosmetics development, including positions at Johnson & Johnson, Avon Products, and DeLaire Inc. From 1993 until 2001, the expert was the Senior Director of Research...
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.