FDA Approval Expert Witnesses in Arkansas

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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

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

    This highly qualified expert has years of experience in the field of neuropharmacology. He received his PhD degree from the University of California, Santa Barbara, and completed his fellowship training at Harvard University. He is a member of various professional associations, including the American Society of Pharmacology and Experimental Therapeutics and the American Chemical Society. He has published 250+ peer reviewed journal articles and has 51+ US issued patents that focus particularly on neurological studies. He also serves as the editor-in-chief for ACS Chemical Neuroscience, lectures both nationally and internationally and has received multiple honors for his outstanding work, including the John J. Abel award in pharmacology. He is the former co-director of the Synthesis Facility at the Vanderbilt Institute of Chemical Biology and the former senior organic chemist at Eli Lilly & Co. Currently, he is a professor of pharmacology and chemistry at a major university, where he is also the director of medicinal chemistry and DMPK at the Center for Neuroscience Drug Discovery. Additionally, he is the director of drug discovery at a major science institute in Tennessee.

    Director, Major Science Institute

    Doctor of Philosophy (PhD), University of California Santa Barbara

    Tennessee

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  • Review Fee
    Deposition Fee
    Court Fee

    This qualified expert of Addiction Psychiatry completed his undergrad and MD in Canada at the McGill University. He completed his post-doc Residency and Fellowship in Psychiatry and Pharmacology in Canada at the University of Toronto. He is Board Certified in the US in Psychiatry & Neurology and in Addiction Psychiatry. He is a member of multiple Addiction Psychiatry Medical Associations and has published 200+ Publications on Addiction Psychiatry Research. He is currently a Professor of Psychiatry at a Top Medical University, the Director of a Top University's Addiction Center, and is the Chief Psychiatrist and Associate Medical Director at a Top University Hospital.

    Professor, A prestigious TN medical school

    Doctor of Medicine (MD), McGill University

    Nashville,

    Tennessee

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

    This highly qualified psychiatric pharmacology expert received a BS in Bacteriology from the Univeristy of California Los Angeles (UCLA) and earned his doctor of pharmacy (Pharm.D.) at the University of Southern California (USC). He had a National Institute of Mental Health (NMH) training fellowship in Psychiatric Pharmacy at the University of Nebraska Medical Center in Omaha, and was recruited to join the faculty of the highly-ranked The University of Texas at Austin College of Pharmacy. He is Board Certified in Psychiatric Pharmacy (BCPP) by the Board of Pharmaceutical Specialties. He serves on the Board of Directors for the College of Psychiatric and Neurologic Pharmacists Foundation and is a founding member of the College of Psychiatric and Neurologic Pharmacists (CPNP). During his 37 years career, this expert has provided clinical care and education in a variety of settings and treatment roles. He teaches didactic and experiential courses for Pharm.D. students and graduate courses for MS and PhD post-Pharm.D. students. He authored and successfully discussed with members of the Texas Legislature the creation of a clinical research unit at San Antonio State Hospital (SASH) that was funded by the Texas Legislature and jointly governed by the UT Austin College of Pharmacy, UT Health Science Center San Antonio Department of Psychiatry and SASH. This expert continues to publish scholarly articles and is regularly invited to do scholarly and lay presentations around the country on a variety of pharmacy and mental health related topics. He was the Senior Founding Editor for a major mental health publication. He edited Psychopharmacology Update newsletter from 1998-2002, and edited two editions of a compendium based upon this newsletter, Psychopharmacology Desktop Reference, published by Manisses Communications Group in 1999 and 2002. He has received several awards reflecting his accomplishments as a clinician, teacher, and researcher.

    Director, A top public research university in TX

    Doctor of Pharmacy (PharmD), University of Southern California

    San Antonio,

    Texas

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  • Review Fee $500/hr

    This expert in EMR and Hospital Billing systems has worked as a certified Epic consultant with various healthcare providers for the past 7 years. He is currently certified in 10 Epic applications ranging from hospital billing to CDM and ASAP. He has previously held positions as a Senior Epic Consultant at multiple hospitals, as an Epic Instructional Designer, and as an Epic Revenue Cycle Report Writer. He is currently a Senior Epic Hospital Billing Consultant at a large university cancer center in Texas.

    Lead Advisor, CVS Health

    Doctor of Chiropractic (DC), Texas Chiropractic College

    Houston,

    Texas

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

    This expert is currently an adviser to the biopharmaceutical industry on matters involving business development, licensing, and strategic partnership. He has also held numerous board positions and currently serves on the board of directors for a clinical stage pharmaceutical company. In addition, he is an Adjunct Professor of Law at a University California. Most recently, he served as the Executive Vice President and General Counsel at Acucela, a development stage company that specializes in identifying and developing novel ophthalmic therapeutics. Previously, he was the Corporate Vice President of Corporate Development and Assistant General Counsel for Allergan Inc. The expert earned his BS of Pharmacy and Doctor of Pharmacy degrees from the State University of New York at Buffalo and a J.D. degree from the University of Southern California Law Center. He holds a certificate in alternative dispute resolution from the Straus Institute of Dispute Resolution of the Pepperdine University School of Law.

    Member of the Board of Directors, A Clinical Stage Pharmaceutical Company

    Certificate (Cert), Pepperdine University School of Law

    Franklin,

    Tennessee

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  • Review Fee $200/hr
    Deposition Fee $275/hr
    Court Fee $350/hr

    This highly qualified pharmacist has extensive experience in her field. She is a board certified critical care pharmacist and received her AAS in chemistry, then her BA in chemistry from the University of Washington, and her Pharm.D from the University of Washington School of Pharmacy. This expert is a licensed pharmacist in TX and WA and is certified by the Washington State Pharmacy Association in immunizations, and in basic life support and pediatric advanced life support. Formerly, she has served as a pharmacist at Kelley-Ross Pharmacy and the MultiCare Good Samaritan Hospital. Additionally, this expert has held the role of clinical pharmacist at Woodland Heights Hospital. Currently, she is a clinical pharmacist at a TX hospital.

    Clinical Pharmacist, A hospital in TX

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

    Texas

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  • This expert has 15 years of experience in clinical pharmacotherapy. He received his PharmD from Campbell University School of Pharmacy and completed his residency in pharmacy practice at Wake Forest University's Baptist Medical Center. He is board certified as a pharmacotherapy specialist. He began his career as a decentralized clinical pharmacist at Wake Forest University before accepting a position as an assistant professor of clinical pharmacy practice and the anticoagulation clinic director at Auburn University. He then went on to be an assistant professor, and eventually associate professor, of clinical pharmacy practice at East Tennessee State University. This expert is heavily involved in pharmacological research, having authored several peer-reviewed articles and presenting on numerous posters at various pharmacy conferences. He currently serves as the vice chair of pharmacy practice and professor of clinical pharmacy practice at a pharmacy program at a Tennessee medical school.

    Professor, A Pharmacy Program in TN

    Doctor of Pharmacy (PharmD), Campbell University

    Tennessee

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  • Review Fee $400/hr
    Deposition Fee $550/hr
    Court Fee $550/hr

    This highly qualified expert has 25 years of experience in pharmacotherapy. He earned both his BS in pharmacy and his PharmD from the University of Missouri. He then completed a clinical pharmacy residency at Truman Medical Center. He is board-certified in pharmacotherapy and a certified geriatric pharmacist. He is active in his field as a member of organizations such as the American Association of Colleges of Pharmacy and the American Society of Consultant Pharmacists. He is also highly involved in pharmacological research, having authored numerous journal articles. His former positions include director of the New Mexico Geriatric Education Center, director of the Center for Pharmaceutical Care for the Elderly at the University of Houston, and director of the Institute for Geriatric Pharmacy at the University of Oklahoma Health Sciences Center. Currently, this expert serves as professor emeritus at a pharmacy college in Oklahoma, as well as the managing partner of a consultancy in Oklahoma.

    Managing Partner, A Consultancy in OK

    Doctor of Pharmacy (PharmD), University of Missouri

    Guthrie,

    Oklahoma

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  • Review Fee $350/hr

    This expert is a well qualified and experienced pharmacy director. He completed his BS in pharmacy at Massachusetts College of Pharmacy and his DPM at New York College of Podiatric Medicine. He also completed a residency in podiatric orthopedics at the Boston VA Medical Center. He is board certified in podiatry and pharmacy. He is active in the field as a member of the American College of Healthcare Executives and the American Society of Hospital Pharmacy among others. He previously served as the pharmacy director for Hubbard Regional Hospital, Forest Park Medical Center, and North Central Surgical Center. He also was a staff pharmacist for Baylor University, Baylor Scott & White, and was a clinical emergency pharmacist for pediatrics at the Children’s Medical Center of Dallas. He currently is the pharmacy director for a medical center in Texas.

    Pharmacist, A pharmacy in ME

    Doctor of Podiatric Medicine (DPM), New York College of Podiatric Medicine

    Ellsworth,

    Texas

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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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