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Average FDA Approval Expert Witnesses Court Fees
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This expert is a board certified internal medicine doctor who has been working as an attending physician in a nursing home for over 30 years. He has extensive experience in dealing with patients who are at higher risk for falls.
Attending Physician, 2 Major Geriatric Health Care Groups
Doctor of Medicine (MD), Northwestern University Medical School
Maryland
This highly qualified Associate Professor earned a masters in Public Health in Epidemiology from the highly regarded Bloomberg School of Public Health. He is board certified in Internal Medicine. He has won many honors throughput his career including the Bruce Squires Award for the Best Research Paper. He is a member of numerous professional societies including the International Society of Pharmacoepidemiology. He serves as a reviewer for more than 50 peer-reviewed medical journals and has published 107 peer-reviewed journal articles. His expertise are highly sought after and he is frequently invited to lecture as a guest speaker both nationally and internationally. He is currently clinically active at a major university affiliated hospital in addition to his academic position.
Clinician-Investigator, A University in MA
Doctor of Medicine (MD), Patna Medical College
Worcester,
Maryland
This expert is board certified psychiatrist and addiction specialist, and also is certified by the American Board of Disability Analysts. He is an expert in handling capital, personal injury, loss mitigation, malpractice and negligence cases that involve the use of abused substances (especially, opiates, alcohol, hallucinogens, and stimulants), prescribed pharmacological agents, and in the general field of psychiatric and brain disease. This expert also is a leading neuroscientist and neuropsychopharmacologist. He can provide expert testimony on the effects of different brain states and function, in both health and disease, and their potential association with with legal culpability and liability. He currently serves as the Chairman of the Department of Psychiatry at a leading university in the USA, and has over 12 years experience as Chairman in Psychiatry Departments in the USA. His research focus is in the neuropsychopharmacology of addiction, addiction and pain, pain treatment, impact of genetics on human behavior, the basic, molecular, and the brain imaging sciences related to the functioning of the brain in health, disease and addiction. In recognition of his academic, scholarly and professional achievement, he is a Fellow of the Collegium Internationale Neuro-psychopharmacologicum and a Distinguished Fellow of the American Psychiatric Association. He is the recipient of numerous professional and scientific awards, including the Jack Mendelson Award at the NIH, which is awarded to individuals who have made distinguished contributions to our understanding of the science of addiction. He has an h-index of 46, and 11829 citations of his published work.
Professor of Psychiatry and Pharmacology, A Prominent East Coast Medical School
Doctor of Philosophy (PhD), University of Glasgow
Miami,
Maryland
This qualified expert has nearly a decade of board-certified experience in his field. He earned his undergraduate degree in premedical education from the Adamjee Government Science College and his MD from the Dow Medical College in Pakistan. He then worked as an administrator, medical officer, and house staff general surgeon in the Civil Hospital of Karachi. He then completed a residency in internal medicine at the University of Texas Medical Branch, Galveston before going on to complete a prestigious fellowship in hematology and oncology from Albert Einstein College/Montefiore Medical Center. This expert is triple board certified in internal medicine, hematology, and medical oncology. He is very active in his field as a member of multiple professional societies including the Society for Immunotherapy of Cancer, the European Society for Medical Oncology, the American Association of Cancer Research, the American Society of Hematology, and the American Society of Clinical Oncology. In addition, this expert has published over 40 peer-reviewed articles. Formerly, this expert served as a physician in hematology and oncology at the Greater Washington Oncology Associates and was the director of clinical oncology at Medimmune/AstraZeneca. He also was a clinical instructor for internal medicine residents at Prince George Hospital. Currently, this expert is a clinical program lead for a biotechnology company and he is an independent practicing physician in hematology and oncology.
Practicing Physician, An independent practice in MD
Doctor of Medicine (MD), Dow Medical College- Pakistan
Chevy Chase,
Maryland
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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.