FDA Approval Expert Witnesses in Nevada

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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

Review Fee

Deposition Fee

Court Fee

FDA Approval Experts in Nevada

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  • Review Fee $700/hr

    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.

    Co-Director, A Muscular Dystrophy Clinic

    Doctor of Medicine (MD), University of Pittsburgh School of Medicine

    Las Vegas,

    Nevada

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Find FDA Approval Expert Witnesses in nearby states

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

    This fellowship-trained doctor received his medical doctorate from the University of Massachusetts School of Medicine. He completed a fellowship in Clinical Pediatric Hematology-Oncology at the prestigious University of Chicago Medical center. He is currently an assistant professor in the department of pediatrics hematology/oncology at a, where he frequently lectures on topics such as vascular abnormalities of the newborn.

    Co-leader, A University-Affiliated Medical Center in CA

    Doctor of Medicine (MD), University of Massachusetts School of Medicine

    Davis,

    California

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  • Review Fee $350/hr
    Deposition Fee $350/hr
    Court Fee $350/hr

    This expert has ~17 years of experience as a pharmacist, with the most recent five years serving as a pharmacy director specializing in clinical pharmacy (inpatient acute care), clinical information systems, safe medical practice, quality improvement, and project management. Earlier in his career, he spent approximately 5 years as a pharmacist in a retail setting. This expert has advised and lead projects and teams on a number of start-up initiatives in the healthcare and information systems marketplace. He has also consulted on five major projects for the County of San Diego, Health, and Human Services Agency.

    Principal Consultant, Private Pharmacy Consulting Firm

    Doctor of Pharmacy (PharmD), University of the Pacific School of Pharmacy

    San Diego,

    California

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  • Review Fee $675/hr
    Deposition Fee $675/hr
    Court Fee $675/hr

    This expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in front of the U.S. Senate as a healthcare policy expert, FDA expert and Pharmacology expert. He has authored or co-authored over 50 publications, papers, articles, reviews, clinical protocols and reports in many related areas including FDA law, drug pricing, healthcare policy, healthcare insurance, drug development and drug patent law.

    Drug Safety Analyst, A research & education institute in VA

    Doctor of Pharmacy (PharmD), University of Arizona

    Washington,

    Arizona

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

    This highly qualified expert earned his Bachelor's degree in Chemistry from the University of California Riverside and his PhD in Comparative Pharmacology and Toxicology from the University of California San Francisco. A member of numerous pharmaceutical societies, he is extremely well published, having authored 120+ peer-reviewed papers and 10 books. He previously served as an Assistant Professor of pharmacology at Washington State University and the University of Southern California. This expert currently serves as an Associate Professor at a top university medical center in southern California.

    Professor Emeritus, A University in CA

    Doctor of Philosophy (PhD), University of California, San Francisco

    Orinda,

    California

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

    This highly qualified expert earned her PharmD from Midwestern University College of Pharmacy Glendale. She continued her post graduate education with a residency in Acute Care Pharmacy Practice and a residency in Geriatrics. She is a member of the American Society of Consultant Pharmacists and a Member of the Arizona Pharmacy Association. This expert has been the recipient of distinguished honors and awards such as AzPA Geriatric Care Academy Service Award. She has published 10 peer-reviewed journal articles. She is a former Visiting Instructor from Midwestern University College of Pharmacy Glendale. She currently serves as current Adjunct Faculty from a major university and a Long Term Care Clinical Consultant Pharmacist from a private consulting group.

    Long Term Care Clinical Consultant Pharmacist, Private Consulting Group

    Doctor of Pharmacy (PharmD), Midwestern University College of Pharmacy Glendale

    Phoenix,

    Arizona

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

    This highly qualified expert earned his BS from George Fox University and PhD from University of California- Los Angeles. He completed a postdoctoral fellowship at The Scripps Research Institute. He is actively involved in research and education; to date he has 60+ original peer reviewed articles/ abstracts. Currently, he is an Assistant Professor of Pharmacology at a major university affiliated medical center. He has been trained in the study of drug discovery and taught on Molecular Pharmacology, Drug Discovery, Molecular Signaling/Transduction for the past few years at two medical schools. His research work includes collaborations with discovery teams to design new drug strategies, synthesize novel drugs, evaluate them in cell culture models, then evaluate their efficacy, side effect profiles, pharmacokinetics, and toxicology in animal models, all with the goal of developing new drugs for human treatment. Most of his research and drug development work is centered on developing new opioid and cannabinoid drugs for chronic pain, cancer treatment, and similar diseases.

    Assistant Professor, A major AZ university

    Doctor of Philosophy (PhD), University of California Los Angeles

    Tucson,

    Arizona

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

    This expert has over 20 years of expertise in the pharmaceutical industry. He holds a Bachelor's degree in Business Management from Georgia Tech and an MBA in Marketing from California Coast University. He has hands on experience in Sales & Marketing, Managed Markets, Distribution, Operations, & Business Development. He has designed & implemented national commercial programs for a variety of drugs.

    Pharmaceutical Consultant

    Master of Business Administration (MBA), California Coast University

    San Clemente,

    California

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  • Review Fee $230/hr
    Deposition Fee $230/hr
    Court Fee $300/hr

    This well-qualified expert is a licensed pharmacist in Utah and Texas. He received his BS in pre-pharmacy from Southern Utah University. He then went on to receive his PharmD from Creighton University School of Pharmacy. He is a certified preceptor in pre-pharmacy for Roseman University and is also CPR certified and certified to administer immunizations. This expert has over 17 years of experience in clinical, retail, compounding, and hospital patient care. He has formerly served as director of pharmacy for Healthsouth, PIC for CVS and pharmacy manager at Walmart. He served as PIC/ overnight manager for CVS pharmacy before going on to his current position as clinical pharmacist for a pharmacy company in Utah.

    Clinical Pharmacist, A Pharmacy Company in UT

    Doctor of Pharmacy (PharmD), Creighton University School of Pharmacy

    Price,

    Utah

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  • Review Fee $350/hr
    Deposition Fee $400/hr
    Court Fee $500/hr

    This highly qualified expert has nearly three decades of experience in the field of pharmaceutical development. She received her BS in biochemistry and organic chemistry and both her DEA and PhD in medicinal chemistry, all from the University Louis Pasteur in Strasbourg, a prestigious French University. She holds 20 patents, mostly in relation to the processing and preparation of pharmaceuticals and is responsible for three finished products as well. She has held a variety of roles within the industry, beginning with several roles as a senior scientist and then moving up to principal scientist at ChemoCentryx, Inc. She then became a consultant for SciMed Partners and Franklin & Associates International LLC. She subsequently transitioned to working with patents, becoming a registered U.S. patent agent and then serving at both Wilson Sonsini Goodrich & Rosati and Morgan, Lewis & Bockius LLP. Currently, she is the founder and principal at a biopharmaceutical company and a co-founder and COO of a second biopharmaceutical company, both located in California.

    Owner, A Pharmaceutical Consulting Firm in CA

    Doctor of Philosophy (PhD), University Louis Pasteur, France

    San Francisco,

    California

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  • This expert has over 15 years of experience in the pharmaceutical industry including sales, operations, marketing, distribution, and project management. This expert earned his BA in business management from Georgia Institute of Technology and later earned his MBA at California Coast University. In addition, this expert is a certified Project Management Professional and is certified in medical sales from the Health Industry Distributors Association. He has held several positions throughout his career including director of national accounts at Valeant Pharmaceuticals, director of managed markets at Mallinckrodt Pharmaceuticals, director of sales, marketing, & operations at Assertio Therapeutics, and director of sales, marketing, & operations at Advanced Mircroclean. This expert is currently an account manager at an independent technology and equipment lessor in California.

    Account Manager, An independent technology and equipment lessor in CA

    Master of Business Administration (MBA), California Coast University

    California

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  • Review Fee $350/hr
    Deposition Fee $350/hr
    Court Fee $350/hr

    This qualified expert pharmacist earned his PharmD from the University of the Pacific and continued to complete a residency at St. Joseph's Medical Center. He then earned his MS in organizational leadership at Southern New Hampshire University and his EdD from the higher education leadership from Aspen University. Today, he is a licensed registered pharmacist, with clinical certifications in geriatrics and psychiatry and remains active in his field as a member of the American Association of Colleges of Pharmacy, the American College of Clinical Pharmacy and the American Public Health Association. Formerly, this expert served as an assistant professor at the University of the Pacific and an associate professor at Roosevelt University and Manchester University, where he also has experience as the chair of the pharmacy practice. Additionally, he was the assistant dean of academic affairs and the chief diversity officer at Pacific University Oregon. Currently, this expert is a professor of pharmacy and an executive associate dean at a health sciences university in California.

    Executive Associate Dean, A health sciences university in CA

    Doctor of Education (EdD), Aspen University

    Clovis,

    California

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  • Court Fee $100/hr

    This highly qualified expert earned her BS in psychobiology from the University of California, Los Angeles and then went on to earn her PharmD at the University of California, San Francisco. She completed an internship at Kaiser Permanente Outpatient Pharmacy and her residency at Kaiser Permanente, Los Angeles Medical Center. She is certified in basic life support, advanced cardiovascular life support, and pediatric advanced life support by the American Heart Association. She was formerly an ambulatory care pharmacist at the Antelope Valley Medical Center. She is currently an inpatient clinical pharmacist and a drug education coordinator at two different medical centers in California.

    Drug Education Coordinator, A Medical Center in CA

    Doctor of Pharmacy (PharmD), University of California, San Francisco

    Monterey Park,

    California

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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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