FDA Approval Expert Witnesses in New Hampshire

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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

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  • Review Fee $500/hr

    This board-certified and fellowship-trained expert has over 40 years of experience working as a clinician and researcher of post-traumatic stress disorder. Listed in "The Best Doctors" in America, he is a Distinguished Lifetime Fellow of the American Psychiatric Association and the past president of the International Society of Traumatic Stress Studies. He has over 300 publications including 27 books and monographs. He currently serves as Professor of Psychiatry and Professor of Pharmacology and Toxicology at a major university medical center. He also serves as Senior Advisor at the Department of Veterans Affairs, National Center for Posttraumatic Stress Disorder

    Senior Advisor, A National PTSD Center

    Doctor of Medicine (MD), University of Kentucky Medical Center

    White River Junction,

    Vermont

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  • Review Fee $600/hr
    Deposition Fee $600/hr
    Court Fee $600/hr

    This expert is a well respected and established Professor of Law specializing in ethics of the healthcare industry. He has testified before Congress and state legislatures and served on government commissions and advisory boards, including the Food and Drug Administration. He has provided training on conflicts of interest related to pharmaceutical good governance for various nations under the aegis of the World Health Organization. He has participated in meetings of the National Academy of Sciences, Institute of Medicine and worked for the World Health Organization. He has extensive experience in the fields of health law and policy, pharmaceutical policy, biomedical law, medical ethics, and more.

    Professor, A Major Law School in Boston

    Doctor of Philosophy (PhD), Brandeis University

    Boston,

    Massachusetts

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

    This highly qualified and board certified psychiatrist has been practice for 33+ years. He earned his BS at the Massachusetts Institute of Technology and MD at Emory University. He completed residency training in psychiatry at Massachusetts General Hospital. This expert is a member of several professional organizations including the American Psychiatric Association and American Academy of Psychiatry and the Law. Currently, he is a clinical instructor at a university affiliated hospital. His clinical and forensic expertise includes assessment of complex diagnoses, treatment of depression, bipolar disorder, ADHD, and anxiety disorders. His expertise also includes dosing, side effects, drug interactions, and toxicity of psychotropic agents.

    Clinical Instructor, An Ivy League university

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

    Cambridge,

    Massachusetts

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

    This expert has over 35 years of experience in the field of psychopharmacology. He earned his BS from Massachusetts Institute of Technology and his MD from Emory University School of Medicine. He completed an internship in general surgery at Boston University Affiliated Hospitals and a residency in psychiatry at Massachusetts General Hospital. He is a member of the American Psychiatric Association, the American Society of Clinical Psychopharmacology, and the American Academy of Psychiatry and Law. He previously served as a staff psychiatrist for Harvard Vanguard Medical Associates, as a clinical supervisor for Lane Health Center at Northeastern University and as a psychopharmacology consultant for the University of Massachusetts. This expert is currently a psychiatrist at a private practice, a staff psychiatrist at a hospital in Massachusetts and a clinical instructor of psychiatry at an Ivy League university.

    Clinical Instructor, An Ivy League university

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

    Cambridge,

    Massachusetts

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  • Review Fee $450/hr
    Deposition Fee $450/hr
    Court Fee $900/hr

    This highly-qualified expert has 14 years of experience in the field of biopharmaceutical development, having earned her BS in biology from the University of North Carolina and her PhD in genetics from the University of California at San Francisco. Her work focuses on drug development with a particular focus on gene and cell therapies, including those with the following elements: AAV, Adenovirus, CRISPR, Zfn, Endonuclease, CAR-T, mRNA, LNP, Lentivirus, HSPC. She has worked in positions such as principal consultant for Halloran Consulting Group, the founder and CEO of Tremont Therapeutics, the senior director of Shire PLC, and the executive director of CRISPR Therapeutics. She is also involved in research in her field as an author of several scientific articles. This expert currently works as the principal at a drug development consulting company in Massachusetts.

    Principal, A drug development consulting company in MA

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

    Charlestown,

    Massachusetts

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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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