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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 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
This highly qualified pharmacology expert obtained his BS in biology from Rockhurst University and his PharmD at the University of Missouri-Kansas City School of Pharmacy. He completed his residency in Pharmacy at Duke University and is certified as a pharmacist, in pharmacotherapy, and medication therapy. This expert is a member of the North American Drug Diversion Investigators, the American Association of Colleges of Pharmacy, and the American Society of Heal-System Pharmacists. He has authored 15+ publications and is currently the founder and CEO of a nutritional supplements laboratory in the midwest. He also serves as a PRN pharmacist at a medical center in Kansas City, an adjunct faculty member at a dentistry school in the mid-west, and a clinical associate professor of pharmacy practice at a midwest university.
Clinical Associate Professor, A Midwest University
Doctor of Pharmacy (PharmD), University of Missouri Kansas City School of Pharmacy
Overland Park,
Kansas
This highly qualified expert has 25 years of experience in pharmacotherapy. He earned both his BS in pharmacy and his PharmD from the University of Missouri. He then completed a clinical pharmacy residency at Truman Medical Center. He is board-certified in pharmacotherapy and a certified geriatric pharmacist. He is active in his field as a member of organizations such as the American Association of Colleges of Pharmacy and the American Society of Consultant Pharmacists. He is also highly involved in pharmacological research, having authored numerous journal articles. His former positions include director of the New Mexico Geriatric Education Center, director of the Center for Pharmaceutical Care for the Elderly at the University of Houston, and director of the Institute for Geriatric Pharmacy at the University of Oklahoma Health Sciences Center. Currently, this expert serves as professor emeritus at a pharmacy college in Oklahoma, as well as the managing partner of a consultancy in Oklahoma.
Managing Partner, A Consultancy in OK
Doctor of Pharmacy (PharmD), University of Missouri
Guthrie,
Oklahoma
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
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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.