FDA Regulations Expert Witnesses in Ohio
We’ll help you retain an industry-leading FDA Regulations expert
Find an expert witness near you
Average FDA Regulations Expert Witnesses Court Fees
$450/hr
Review Fee
$525/hr
Deposition Fee
$550/hr
Court Fee
Find FDA Regulations Expert Witnesses in nearby states
Medical Device Regulations Expert Witness
Review Fee $400/hrDeposition Fee $400/hrCourt Fee $450/hrThis highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former positions include research engineer for Eastman Kodak and GAF Corporation, project manager and laboratory supervisor for Biosearch Medical Products and Hydromer, and corporate manager of materials for Arrow International. Currently, this expert is the president of a medical device consulting company in Pennsylvania.
President, A medical device consulting company in PA
Master of Science (MS), SUNY Binghamton
Blandon,
Pennsylvania
Related Specialties
Find Fda Regulations Expert Witnesses In:
What Can a FDA Regulations Expert Witness Opine On?
New Drug Application (NDA)
Process for seeking FDA approval of drugs.
Investigational New Drug (IND) Application
Request to begin clinical trials on drugs.
Biologics License Application (BLA)
Application for approval of biological products.
Abbreviated New Drug Application (ANDA)
Application for generic drug approval.
Food Facility Registration
Registration of food manufacturing facilities.
Labeling Compliance Review
Evaluation of product labeling for compliance.
FAQs for Fda Regulations Expert Witnesses
What is a fda regulations expert witness?
An FDA regulations expert witness is a specialist who explains how FDA laws and compliance standards apply to a case. They assist by reviewing records, preparing opinions, testifying, and clarifying regulatory issues.
What types of cases may benefit from the expertise of an FDA Regulations expert witness?
An FDA regulations expert witness handles cases involving drug and device approvals, labeling, advertising, clinical trials, GMP compliance, recalls, and regulatory enforcement.
How can an FDA-regulations expert witness strengthen regulatory causation arguments?
An FDA-regulations expert witness strengthens regulatory causation arguments by linking specific FDA standards, compliance gaps, and regulatory history directly to the alleged harm.
What qualifications should counsel prioritize when selecting an FDA-regulations expert witness?
Counsel should prioritize an FDA-regulations expert witness with direct FDA or industry experience, advanced regulatory credentials, case-testifying history, and strong scientific or legal training.
How does an FDA-regulations expert witness evaluate compliance with labeling requirements?
An FDA-regulations expert witness evaluates labeling compliance by comparing product labels to FDA statutes, regulations, guidance, and enforcement history to identify gaps or violations.
What is Expert Institute’s process for selecting fda regulations 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.