FDA Approval Expert Witnesses in New York

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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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Average FDA Approval Expert Witnesses Court Fees

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Deposition Fee

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FDA Approval Experts in New York

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  • 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.

    Executive VP, Private medical technologies firm

    Graduate Studies

    New York

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  • Review Fee $400/hr
    Deposition Fee $500/hr
    Court Fee $500/hr

    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 Pharmaceutical literature with over 350 articles. In addition to his academic role he currently serves as CEO of three Pharmaceutical companies.

    Emeritus Professor of Pharmaceutical Sciences, Major University

    Doctor of Pharmacy (PharmD), Philadelphia College of Pharmacy and Science

    Buffalo,

    New York

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

    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, and treatment. He has been a special government employee consultant for the US Department of Health and Human Services, Public Health Service Food and Drug Administration, and Center for Drug Evaluation. He has numerous patents, trademarks, fellowships, grants, and publication and presentations.

    Lecturer, A Medical Society in NY

    Doctor of Medicine (MD), Chicago Medical School

    Glen Cove,

    New York

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

    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 is also the past president of the International Neurotoxicology Association. He has authored approximately 300 peer-reviewed manuscripts and chapters in the area of neurotoxicology and serves on the editorial board of several journals. He is the former director of clinical pharmacology and toxicology at Vanderbilt and the former director of the NIEHS Molecular Toxicology Center. Currently, he is a professor and chair of molecular pharmacology at a major university in New York.

    Professor, A Prestigious University in NY

    Doctor of Philosophy (PhD), University of Rochester

    Bronx,

    New York

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  • Review Fee $176/hr
    Deposition Fee $250/hr

    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 and Development for Gryphon Development / Bath & Body Works Inc. / Victoria Secret Beauty. In this position, he developed formulations for treatment products, cleansing products, and OTC drugs. The expert currently runs his own independent cosmetics development consultancy, through which he has worked with firms including Bath and Body Works, Unilever Latin America, Morning Glory Products, and many others.

    Founder & Chief Consultant, Private Cosmetics Development Consultancy

    Doctor of Philosophy (PhD), University of Iowa

    New City,

    New York

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  • Review Fee $150/hr
    Deposition Fee $150/hr
    Court Fee $200/hr

    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 American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.

    Senior Associate Dean, School of Pharmacy, Major University

    Master of Business Administration (MBA), University at Buffalo

    Getzville,

    New York

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  • Review Fee $200/hr
    Deposition Fee $250/hr
    Court Fee $250/hr

    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 Association of Pharmaceutical Scientists and holds a patent related to transdermal drug delivery. He formerly held roles in formulation development at Lincoln Pharmaceutical, Torrent Pharmaceuticals, and Apex Pharmaceuticals, and served as an assistant research scientist at Transdermal Research Pharm Laboratories. This expert is currently a principal scientist at a pharmaceutical laboratory in New York.

    Principal Scientist, A Pharmaceutical Lab in NY

    Doctor of Philosophy (PhD), Long Island University

    Plainview,

    New York

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

    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 articles and as a member of several organizations, including the American Society of Health-System Pharmacists and the Pediatric Pharmacy Advocacy Group. He has formerly served as a pharmacist for Brooks Pharmacy, the Medical University of South Carolina, Mary Imogene Bassett Hospital, and Griffin Hospital. He also served as the director of pharmacy for Option Care (Infucor), a clinical pharmacy specialist at Yale-New Haven Hospital, and the director of pharmacy at Upstate University Hospital. Currently, this expert is the executive director of pharmacy services at a university-affiliated hospital in New York.

    Contract lead surveyor, A national medical society

    Doctor of Pharmacy (PharmD), Shenandoah University

    New York

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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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