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Average FDA Approval Expert Witnesses Court Fees
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This well-qualified expert is a licensed pharmacist in Utah and Texas. He received his BS in pre-pharmacy from Southern Utah University. He then went on to receive his PharmD from Creighton University School of Pharmacy. He is a certified preceptor in pre-pharmacy for Roseman University and is also CPR certified and certified to administer immunizations. This expert has over 17 years of experience in clinical, retail, compounding, and hospital patient care. He has formerly served as director of pharmacy for Healthsouth, PIC for CVS and pharmacy manager at Walmart. He served as PIC/ overnight manager for CVS pharmacy before going on to his current position as clinical pharmacist for a pharmacy company in Utah.
Clinical Pharmacist, A Pharmacy Company in UT
Doctor of Pharmacy (PharmD), Creighton University School of Pharmacy
Price,
Utah
This board-certified and fellowship-trained expert has over 20 years of experience in neurology with extensive clinical research experience, contributing to over 55 different clinical studies. He has involved in various committees for the University of Nevada School of Medicine. He currently serves as Associate Professor of Neurology and Medical Director for an ALS and muscular dystrophy clinic.
Co-Director, A Muscular Dystrophy Clinic
Doctor of Medicine (MD), University of Pittsburgh School of Medicine
Las Vegas,
Nevada
This expert is a pharmacist and a pharmacologist and a former professor at Yale University and Georgetown University. He is also a former FDA Medical Officer/Senior Medical Analyst, who is an expert in the areas of drug Safety, drug development, regulatory affairs and FDA policy. He as also served as an advisor on the 2016 Ted Cruz presidential campaign, and has also been invited to testify in front of the U.S. Senate as a healthcare policy expert, FDA expert and Pharmacology expert. He has authored or co-authored over 50 publications, papers, articles, reviews, clinical protocols and reports in many related areas including FDA law, drug pricing, healthcare policy, healthcare insurance, drug development and drug patent law.
Drug Safety Analyst, A research & education institute in VA
Doctor of Pharmacy (PharmD), University of Arizona
Washington,
Arizona
This expert is a licensed pharmacist and associate professor of clinical pharmacy at a top university pharmacy school. She earned her PharmD at the University of the Pacific and belongs to a number of prestigious societies in the pharmacy space, including the American Association of Colleges of Pharmacy and the American Society of Health System Pharmacists. She has served in various pharmaceutical positions throughout her career and has authored more than 20 publications in the field.
Assistant Professor, A Top University Pharmacy School
Master of Business Administration (MBA), University of Colorado Denver
Aurora,
Colorado
This highly qualified expert earned her PharmD from Midwestern University College of Pharmacy Glendale. She continued her post graduate education with a residency in Acute Care Pharmacy Practice and a residency in Geriatrics. She is a member of the American Society of Consultant Pharmacists and a Member of the Arizona Pharmacy Association. This expert has been the recipient of distinguished honors and awards such as AzPA Geriatric Care Academy Service Award. She has published 10 peer-reviewed journal articles. She is a former Visiting Instructor from Midwestern University College of Pharmacy Glendale. She currently serves as current Adjunct Faculty from a major university and a Long Term Care Clinical Consultant Pharmacist from a private consulting group.
Long Term Care Clinical Consultant Pharmacist, Private Consulting Group
Doctor of Pharmacy (PharmD), Midwestern University College of Pharmacy Glendale
Phoenix,
Arizona
This highly qualified expert earned his BS from George Fox University and PhD from University of California- Los Angeles. He completed a postdoctoral fellowship at The Scripps Research Institute. He is actively involved in research and education; to date he has 60+ original peer reviewed articles/ abstracts. Currently, he is an Assistant Professor of Pharmacology at a major university affiliated medical center. He has been trained in the study of drug discovery and taught on Molecular Pharmacology, Drug Discovery, Molecular Signaling/Transduction for the past few years at two medical schools. His research work includes collaborations with discovery teams to design new drug strategies, synthesize novel drugs, evaluate them in cell culture models, then evaluate their efficacy, side effect profiles, pharmacokinetics, and toxicology in animal models, all with the goal of developing new drugs for human treatment. Most of his research and drug development work is centered on developing new opioid and cannabinoid drugs for chronic pain, cancer treatment, and similar diseases.
Assistant Professor, A major AZ university
Doctor of Philosophy (PhD), University of California Los Angeles
Tucson,
Arizona
This expert earned his BS in health and exercise science and his MS in toxicology from Colorado State University and his MS in health services administration with a concentration in biopharmaceutical regulatory compliance and his PharmD from the University of Wyoming. He is active in his field as a member of the National Community Pharmacists Association and the American Pharmacist Association. He formerly served as a pharmacy intern and the flu clinic supervisor for the student health pharmacy at the University of Wyoming. Currently, this expert is a medical content writer for a medical consulting firm.
Medical Content Writer, A medical consulting firm
Doctor of Pharmacy (PharmD), University of Wyoming
Colorado
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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.