We’ll help you retain an industry-leading FDA Regulations expert
Average FDA Regulations Expert Witnesses Court Fees
$450/hr
Review Fee
$525/hr
Deposition Fee
$550/hr
Court Fee
This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in nursing and her MS in perinatal nursing from the University of Illinois at Chicago. She then went on to earn a post-masters certificate in midwifery from the State University of New York at Stony Brook and her PhD in perinatal epidemiology from the University of Maryland at Baltimore. This expert is a certified nurse-midwife and a licensed registered nurse. She is active in her field as a member of several organizations, including the American Nurses Association, the American College of Nurse-Midwives, and the American Academy of Nursing. She is also highly involved in research, having authored several peer-reviewed journal articles and book chapters and spoken at multiple scientific conferences throughout her career. For her work, she has been the recipient of numerous honors and awards. With over 15 years in academia, this expert has formerly served as an assistant professor of child, women and family health at the University of Maryland, and adjunct assistant professor in prevention and community health and an adjunct clinical associate professor of clinical management and leadership at George Washington University, and, most recently, as an adjunct associate professor at the Uniformed Services University of the Health Sciences. Clinically, she has served as an maternal child health epidemiologist and a health sciences administrator for the United States Department of Health and Human Services and the CDC and has worked extensively with the FDA as an epidemiologist and branch chief for the FDA's Center for Devices and Radiological Health. Additionally, she served as the director of women's health, medical ethics and patient advocacy for the Office of the Assistant Secretary of Defense. Currently, this expert is the owner and CEO of an epidemiology consulting group based in Maryland.
Adjunct Associate Professor, A University in DC
Doctor of Philosophy (PhD), University of Maryland at Baltimore
Derwood,
Maryland
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.