We’ll help you retain an industry-leading FDA Approval expert
Average FDA Approval Expert Witnesses Court Fees
Review Fee
Deposition Fee
Court Fee
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 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
This expert holds a doctorate degree in toxicology and has been a practicing toxicologist for over 40 years. Board certified by the American Board of Toxicology and a Fellow of the Academy of Toxicological Sciences, he had published over 35 scientific articles and is a former president of the Mid-Atlantic chapter of the Society of Toxicology. He spent over 30 years as a Director of Toxicology for two major pharmaceutical companies and currently serves as an independent toxicology consultant.
Consultant in Toxicology and Drug Safety
Doctor of Science (ScD), University of Cincinnati
Blue Bell,
Pennsylvania
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 highly qualified expert has years of experience in assessing, developing and executing regulatory strategies. He is board certified in internal medicine and endocrinology and has been practicing for 34+ years. He received his PhD degree from Washington University and completed his residency training at Yale-New Haven Hospital. He is a fellow of the American College of Physicians and a member of multiple other professional societies, including the Endocrine Society and the American Diabetes Association, which honored him with its "Outstanding Service Award" in 1991. He has published 16+ peer-reviewed journal articles and lectures nationwide. He is the former executive director of global regulatory strategy, policy and safety at Merck Research Laboratories and the former chief of the diabetes program branch at the National Institute of Health. He is also a former consultant in the division of metabolism and endocrine drug products at the FDA. Currently, he is the owner of an individual pharmaceutical/regulatory consulting company in Pennsylvania.
Owner, Pharmaceutical Consulting Company
Doctor of Philosophy (PhD), Washington University
Dresher,
Pennsylvania
This highly qualified expert has years of experience in using animal models to study diabetes. He received his PhD degree from Ohio State University and completed his fellowship training in physiology and biophysics at the University of Illinois. He has published 98+ peer-reviewed journal articles and serves as a reviewer for 26+ renowned medical journals. He has been listed in "Who's Who in America" for science and engineering and lectures nationwide. Currently, he is a professor of pharmaceutical science and research and the director of pharmacology and toxicology at a major university. He is also the director of the Center for Diagnostic Nanosystems and the associate director of the Cell Differentiation and Development Center at the same institution. Additionally, he is the biological sciences laboratory supervisor at another major university.
Laboratory Supervisor, Major University
Doctor of Philosophy (PhD), Ohio State University
Huntington,
West Virginia
This accomplished expert received his BA in Biology from the State University of New York at Buffalo and his DO at the New York College of Osteopathic Medicine. He completed his fellowship in Pediatric Anesthesia at the Children's Hospital of Philadelphia, is board certified in Pediatrics, Anesthesiology, and Pediatric Anesthesiology, and is certified in Advanced Cardiac Life Support and Pediatric Advanced Life Support. He is an active member in the International Anesthesia Research Society and the Medical Director of the Malignant Hyperthermia Association of the United States, and the Medical Director of the Institute for Safe Medication Practices. This expert is also currently a member of the FDA's Anesthesia and Analgesia Drug Advisory Committee. His research focuses on medication safety, malignant hyperthermia, and many different aspects of pediatric anesthesia safety. Formerly, he was the Chief of Pediatric Anesthesia at the University of Rochester, and an attending Anesthesiologist at Strong Memorial Hospital. Currently, he is a professor of Pediatrics and Professor of Anesthesiology & Critical Care and Pediatrics at a prestigious university, as well as an attending anesthesiologist at a children's hospital in Pennsylvania.
Attending Anesthesiologist, A Children's Hospital in Pennsylvania
Doctor of Osteopathic Medicine (DO), New York College of Osteopathic Medicine
Philadelphia,
Pennsylvania
This expert has served the Drug Enforcement Administration for 21 years before entering the private sector. He gained a BA in law enforcement administration from Youngstown State University and was a state trooper for the Maryland State Police for 7 years before joining the DEA. At the DEA, he investigated international and domestic crime organizations, seizing millions of dollars in drug-related assets. This expert has been decorated numerous times and has been honored by the Attorney General for his service.
Private Investigator, A Consulting Service
Bachelor of Arts (BA), Youngstown State University
New Castle,
Pennsylvania
This expert has over 15 years experience in academia as it relates to Pharmacology. He has been accredited with the discovery of the RGS protein family, leading to 4 issued patents and numerous publications. In 2004 he was awarded the John Abel Award as an Outstanding American Pharmacologist under 40, from the American Society for Pharmacology & Experimental Therapeutics (ASPET). He is currently not only a Professor of Pharmacology, but also the Chair of the department and Director of the MD/PhD Scholars program at a University in West Virginia.
Professor, An Osteopathic Medicine College in TX
Doctor of Philosophy (PhD), University of Toronto
Fort Worth,
West Virginia
This highly qualified expert earned his undergraduate pharmacy degree from West Virginia University. He is certified by The American Pharmacist Association in Medication Therapy Management and Immunization. He is active in his field as a member of numerous medical organizations including The American Society of Health Systems Pharmacists. He has published multiple papers in his field and delivered over 20 invited lectures and presentations. He has served in numerous managerial roles at pharmacies across the West Virginia Area. Currently, he is Chair and Assistant Professor of Pharmacy Practice at a university in West Virginia.
Chair, WV based university
Bachelor of Science (BS), West Virginia University
Ripley,
West Virginia
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 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
Related Specialties
Find Fda Approval Expert Witnesses In:
Alabama
Arizona
Arkansas
California
Colorado
Connecticut
Delaware
Florida
Georgia
Idaho
Illinois
Indiana
Iowa
Kansas
Kentucky
Louisiana
Maryland
Massachusetts
Michigan
Mississippi
Missouri
Nebraska
Nevada
New Hampshire
New Jersey
New Mexico
New York
North Carolina
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Vermont
Virginia
Washington
West Virginia
Wisconsin
Wyoming
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.