FDA Approval Expert Witnesses in North Carolina

We’ll help you retain an industry-leading FDA Approval expert

FDA approval expert witnesses practice in a variety of fields, including pharmaceuticals, medical devices, food safety, biotechnology, and clinical trials. Some of the most common FDA approval expert witness specialties also include drug labeling, dietary supplements, cosmetic products, veterinary medicine, and tobacco products. They can opine on the effects of regulatory compliance, product recalls, adverse event reporting, post-market surveillance, and risk management.

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Average FDA Approval Expert Witnesses Court Fees

Review Fee

Deposition Fee

Court Fee

FDA Approval Experts in North Carolina

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Review Fee $250/hr
Deposition Fee $250/hr

This certified compounding pharmacist has received his training from a top pharmacy program and holds clinical and academic positions in his field at both pharmacy and medical schools. He has given invited lectures on compounding pharmacy, and has authored major publications on the topic. Furthermore, he has been in practice since 1977 and has owned a compounding-only pharmacy since 2003. He serves on the North Carolina Board of Pharmacy and the USP Compounding Expert Committee for the 2010-2015 cycle. Memberships include the American Society for Pharmacy Law and the National Associations of Boards of Pharmacy.

Clinical Associate Professor, A major pharmacy college

Master of Science (MS), University of North Carolina, Chapel Hill

Hickory,

North Carolina

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Review Fee $325/hr
Deposition Fee $425/hr
Court Fee $425/hr

This highly-qualified expert has over 15 years of experience as a pharmacist dealing with issues like medication safety, medication errors, and medication policy. She earned her PharmD from the University of North Carolina before completing a drug information specialty residency at Thomas Jefferson University Hospital. This expert is a licensed pharmacist in North Carolina and is certified by the American Heart Association in basic life support. She is active in her field as a member of the American Society of Health-System Pharmacists, a researcher on several pharmacy research studies, an author of multiple pharmacy publications, and a speaker at several industry conferences throughout her career. She has formerly served as a clinical instructor at the University of the Sciences in Philadelphia, a clinical pharmacist in the ambulatory setting at the Duke Outpatient Clinic, and a clinical pharmacist in medication safety at Duke University Medical Center. This expert currently serves as a clinical pharmacist for drug information at a university-affiliated medical center and as the preceptor for the drug information rotation at two North Carolina universities.

Clinical Pharmacist, Drug Information, A University-Affiliated Medical Center in NC

Doctor of Pharmacy (PharmD), University of North Carolina

Durham,

North Carolina

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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 the role of an FDA Approval expert witness in a legal case?

An FDA Approval expert witness provides insight on regulatory compliance, drug approval processes, and medical device clearance. They can testify on whether proper procedures were followed.

What types of cases might require an FDA Approval expert witness?

Cases involving pharmaceuticals, medical devices, food safety, and cosmetics often require an FDA Approval expert witness. These experts are crucial in product liability or patent infringement cases.

How can an FDA Approval expert witness assist in a pharmaceutical litigation case?

In pharmaceutical litigation, an FDA Approval expert can provide testimony on drug development, clinical trials, labeling requirements, and post-market surveillance to establish if there was any negligence.

Are there subspecialties within the field of FDA Approval for expert witnesses?

Yes, some experts specialize in specific areas like pharmaceuticals, medical devices, biologics, dietary supplements, or food products depending on their experience with FDA regulations.

Why is it important to hire an FDA Approval expert witness with recent industry experience?

Regulations and guidelines from the FDA frequently change. An expert with recent industry experience will have up-to-date knowledge about these changes and how they impact your case.

How does Expert Institute select its FDA Approval expert witnesses?

Expert Institute offers a personalized approach to help you find the highest quality experts. We source actively-practicing professionals who match all your requirements for specialty areas, work experience, litigation history, fee range, certifications, location, and more.

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