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This highly qualified expert is a licensed pharmacist practicing in the state of Florida for the past 36 years. He has filled 500,000+ prescriptions, performed 150,000+ medical chart reviews, and participated in 200+ state and federal surveys. He completed his post baccalaureate studies in biochemistry and pharmacy at the University of Florida and is board certified in geriatrics pharmacy. He is a member of the American Society of Consultant Pharmacists and the former pharmacy manager of numerous pharmacy groups, including RX Express Pharmacy Inc. and CR Pharmacy Inc. He is also the former president of Select Pharmacy Services and the former director of consulting services at Medistat Pharmacy Services. Currently, he is the director of consultant and management services at a major health advisors group and a professor of pharmacy at three major pharmacy colleges.
Clinical Assistant Professor, A College of Pharmacy in FL
Bachelor of Science (BS), University of Florida
Miami,
Florida
This highly qualified expert has over 30 years of experience in pharmacy. His work focuses on hospital pharmacy, pharmacy sterile compounding, medication and patient safety, pharmacy regulatory issues, and pharmacy management and employee relations. He earned his BS in pharmacy from the University of Georgia and is a certified pharmacy regulatory specialist and USP 797 trainer. He has formerly served as a staff pharmacist at Baptist Health System South Florida, a pharmacy sterile admixture supervisor at Baptist Hospital Miami, and a hospital pharmacist at the University of Miami. Currently, this expert is the owner and president of a pharmacy training company and a clinical staff pharmacist for a hospital system in Florida.
Clinical Staff Pharmacist, A Hospital System in FL
Bachelor of Science (BS), University of Georgia
Miami,
Florida
This highly-qualified expert has over 45 years of experience as a pharmacist, with experience in compounding pharmacy, including both federal and state regulatory and understanding third party relationships, such as PBM’s. He earned his BS in pharmacy from Ohio State University before beginning his career as pharmacy department manager in the retail pharmacy sector. He has formerly served as operations manager, operations director, and director of pharmacy and regulatory affairs and quality for AnazaoHealth Corporation. He has also served as the vice president of pharmacy and quality assurance for Wells Pharmacy Network and the president and general director of Physician Specialty Compounding. Currently, this expert is the pharmacist in charge at a sterile compounding pharmacy in Florida.
Pharmacist in Charge, A Sterile Compounding Pharmacy in FL
Bachelor of Science (BS), Ohio State University
Florida
This highly qualified expert in pediatric pharmacy practice earned his PharmD at Lebanese American University and completed his residency training at Harper University Hospital and Wayne State University. In addition to being a registered pharmacist, this expert is board certified as a pediatric pharmacy specialist. Among his former roles, he served as a clinical pharmacist at Miami Children’s Hospital, Orlando Regional Medical Center, and Nemours Children’s Hospital. Since 2016, this expert has been a clinical pharmacy specialist at a regional medical center in Florida, where he participates in the development, implementation, and monitoring of clinical pharmacy practices within the center's neonatal intensive care, nursery, general pediatrics, and pediatric intensive care units. He also serves as an active member of his institution's pharmacy and therapeutics committee and antimicrobial stewardship committee.
Clinical Pharmacy Specialist, A Regional Medical Center in FL
Doctor of Pharmacy (PharmD), Lebanese American University
Orlando,
Florida
This expert has extensive experience in psychiatric pharmacy. He completed his BS in biology and chemistry and his PharmD from the University of Wyoming. He then completed two residencies in pharmacy and ambulatory care from the VA Black Hills Healthcare System. Board-certified as an ambulatory care pharmacist, pharmacotherapy specialist, and psychiatric pharmacist, this expert is active in his field as a member of the American College of Clinical Pharmacy, the Academy of Integrative Pain Management, and the College of Psychiatric and Neurologic Pharmacists. He previously served as a pharmacist at the VA Black Hills Healthcare System and as a clinical assistant professor of pharmacy at the South Dakota State University. He was also a clinical pharmacy specialist t the VA Black Hills Healthcare System and the Sheridan VA Medical Center. This expert currently works as a consultant for a biotech company and as the associate chief and pharmacy specialist at a VA medical center in Florida.
Associate Chief, Pharmacy Specialist, A VA Medical Center in FL
Doctor of Pharmacy (PharmD), University of Wyoming
Tampa,
Florida
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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.