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Average FDA Approval Expert Witnesses Court Fees
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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 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 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
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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.