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Average FDA Approval Expert Witnesses Court Fees
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This expert has over 25 years of experience in analytical chemistry including pharmaceutical development. With a Ph.D. from the prestigious Massachusetts Institute of Technology, he has published in analytical and physical chemistry. His previous positions include various lead positions of research and development as well as analytical testing. He currently serves as a Senior Vice President of an analytical services firm.
Vice President of Chemical and Pharmaceutical Analysis, Analytical Testing and Pharmaceutical Development Firm
Master of Technology Management (MTM), Stevens Institute of Technology
Ann Arbor,
Michigan
This expert is a licensed pharmacist and has over 30 years of experience in clinical pharmacy, with her work focusing on areas including opioid use disorder, pharmacy-related fraud, health system, physician organization, health plans, and specialty drug & PBM pharmacy practice. She completed her PharmD at the University of Michigan. This expert is an active member of numerous professional organizations including the Academy of Managed Care Pharmacy, American Society of Health-System Pharmacists, and the Michigan Pharmacists Association. This expert has 9 peer-reviewed academic publications and has been invited to present numerous times in her field nationally. She has extensive teaching experience as a preceptor at multiple universities and as the pharmacy practice and pharmacoeconomic residency director at St. John Hospital and Medical Center. Previously, she held a role as vice-president of clinical pharmacy programs and services at ArchimedesRx. She is currently the owner of a pharmacy consulting firm in Michigan and specializes in clinical pharmacy leadership and managed care pharmacy.
Owner, A Pharmacy Consulting Firm in MI
Doctor of Pharmacy (PharmD), University of Michigan
Brighton,
Michigan
This highly qualified expert earned her BS and MS from The Ohio State University. She has been in the health informatics field for over three decades and has extensive experience with clinical informatics and pharmacy operations. Formerly, she was Associate Director of The Department of Pharmacy at Ohio State and also served as Practice Manager for Allscripts (an EMR database). Currently, she is an Independent Healthcare Consultant in the Ohio area.
Consultant, An independent electronic healthcare records consultancy in OH
Master of Science (MS), Ohio State University
Westerville,
Ohio
This clinical development and regulatory expert has an M.S and Ph.D. in Pharmacology & Toxicology from West Virginia University. A member of the American Society of Clinical Pharmacology & Therapeutics, he has extensive product development experience in the pharmaceutical field. The expert spent his early career in clinical research roles, including a position as the Director of Clinical Research Operations for Univax Biologics. He has since founded/run a biotech development business and acts as both a Professor and Consultant in his field.
Contract Medical Writer, OH
Doctor of Philosophy (PhD), West Virginia University
Cincinnati,
Ohio
This highly-qualified expert has 15 years of experience in pharmacology. He received his AA in chemistry and pre-pharmacy from Santa Fe College before earning his PharmD from the University of Florida. He subsequently completed a residency in primary care with an emphasis on infectious diseases and HIV at the Bay Pines VA Healthcare System. This expert is currently board-certified in infectious diseases pharmacy and is certified in antimicrobial stewardship pharmacy, core clinical research training, and HIV pharmacy. He is active in his field as a fellow of the Infectious Diseases Society of America and a member of several associations, including the American College of Clinical Pharmacy and Society of Infectious Disease Pharmacists. He is also involved in research, having authored multiple peer-reviewed articles, spoken at numerous pharmacy conferences, and served on the IRB for various hospitals and universities. His former positions include director of the antimicrobial stewardship program at Bay Pines VA Healthcare System, associate professor of infectious diseases at Presbyterian College, and associate professor of biomedical sciences at Virginia College of Osteopathic Medicine. Currently, this expert serves as a clinical pharmacist at an infectious disease clinic in Indiana, as well as adjunct faculty of pharmacotherapy and translational research at a pharmacy school in Florida.
Infectious Diseases Specialty Clinical Pharmacist, A Regional Medical Center in IN
Doctor of Pharmacy (PharmD), University of Florida
Johnson City,
Indiana
This highly-qualified expert has nearly 45 years of experience in pharmacology. He specializes in pediatric clinical pharmacology, toxicology, and clinical pharmacy, as well as adverse drug reactions, drug-drug-food interactions, pharmacokinetics-pharmacodynamics, and pharmacogenomics. He earned both his BS in pharmacy and his PharmD from the University of Cincinnati. He also completed an internship in community pharmacy at Winston Place Pharmacy, an internship in hospital pharmacy at Holmes Hospital, and a residency in pediatric clinical pharmacy and clinical pharmacology at Children's Hospital Medical Center. This expert is board certified in applied pharmacology by the American Board of Clinical Pharmacology. He is active in his field as a member of the American Society of Hospital Pharmacists and the American College of Clinical Pharmacology. He has formerly served as the co-director of pediatric clinical pharmacology and toxicology at Rainbow Babies and Children's Hospital and the director of the clinical research center at Akron Children's Hospital. Additionally, he has held a variety of teaching positions, including as a tenured professor of pediatrics in the division of pediatric pharmacology and critical care at Case Western Reserve University and as a professor of pediatrics at Northeast Ohio Medical University. Currently, this expert is a professor emeritus of pediatrics at an Ohio university.
Professor Emeritus, A University in OH
Doctor of Pharmacy (PharmD), University of Cincinnati
Chagrin Falls,
Ohio
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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.