FDA Regulations Expert Witnesses in Minnesota
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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
FDA Regulations Congressional oversight Expert Witness
Review Fee $500/hrDeposition Fee $500/hrCourt Fee $500/hrThis expert is the president of a healthcare government relations and regulatory policy consultancy firm that she founded after an extensive career in healthcare and government. She was the Vice President for Government Relations and Public Policy at Celgene and was the Vice President for Regulatory Policy at GE Healthcare. She served in the administration of President George H.W. Bush as Special Assistant for Legislative and Public Affairs in the Office of the Commissioner, US Food and Drug Administration. She is a certified Regulatory Affairs specialist and is the author of numerous reports and is currently on the Board of Directors of the FDA Alumni Association. Her formal education includes a BA in Government from Georgetown University and an MS in Science and Technology Commercialization from The University of Texas at Austin.
President, A Biotech Consultancy
Master of Science (MS), University of Texas at Austin
Milwaukee,
Wisconsin
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.