FDA Approval Expert Witnesses in Indiana

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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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Mark L Westerman, MBAView profile

ID: 126753

Mr. Mark Westerman, MBA

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Indiana

Mr. Mark Westerman has over 20 years of experience in Project Management and Compliance for the Pharmaceutical, Biotechnology, and Insurance industries. He earned his AA in Business Transfer Studies from Polk State College, BA in Business Administration and Management from the University of Central Florida, and MBA from Indiana State University. Today, this expert is Scrum Master Certified as...

Infectious Diseases Pharmacology Expert WitnessView profile

E-498195

Infectious Diseases Pharmacology Expert Witness

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Indiana

This highly-qualified expert has 15 years of experience in pharmacology. He received his AA in chemistry and pre-pharmacy from Santa Fe College before earning his PharmD from the University of Florida. He subsequently completed a residency in primary care with an emphasis on infectious diseases and HIV at the Bay Pines VA Healthcare System. This expert is currently board-certified in infectious...

Brian R OverholserView profile

ID: 27720

Dr. Brian Overholser

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Indiana

This highly qualified pharmacology expert earned his PharmD and a post-doctoral fellowship in pharmacokinetics/pharmacodynamics from Purdue University. He is very active in his field as a member of the American Association of Colleges of Pharmacy, the Indiana College of Clinical Pharmacy, and the American College of Clinical Pharmacy. In addition, he has published over 35 peer-reviewed articles...

George CalafactorView profile

ID: 12766

Mr. George Calafactor

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Indiana

This highly-qualified expert has decades of experience working in medical device regulation and compliance. He earned a BS in chemistry as well as metallurgical engineering from the University of Notre Dame, an MS in regulatory affairs at Northeastern University, and an MBA in international business at Indiana University. He is a certified quality biomedical auditor and a certified medical device...

FDA Approval Expert Witness FAQs

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.

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.

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.

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

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.

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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