FDA Regulations Expert Witnesses

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FDA regulations expert witnesses practice in a variety of fields, including pharmaceuticals, food safety, medical devices, biotechnology, and cosmetics. Some of the most common FDA regulations expert witness specialties also include drug safety, labeling compliance, dietary supplements regulation, clinical trials oversight, and quality control. They can opine on the effects of regulatory compliance, product recalls, adverse event reporting, Good Manufacturing Practices (GMP), and new drug approval processes.

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Robin Cooper Feldman, JDView profile

ID: 164889

Prof. Robin Cooper Feldman, JD

Prof. Robin Feldman has 32 years of experience in the fields of Intellectual Property, Health, and Medicine. She earned her BA in International Relations from Stanford University and her JD from Stanford Law School. Formerly, this expert served as a Law Clerk at the United States Court of Appeals for the Ninth Circuit. Currently, she serves as the Director of the Center for Innovation, as an...

Forensic Legal Analysis Expert Witness | GeorgiaView profile


Forensic Legal Analysis Expert Witness | Georgia

This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic...

Amy Gartland Egan, MD, MPHView profile

ID: 1992589

Dr. Amy Gartland Egan, MD, MPH

Dr. Amy Egan has over 15 years of experience in FDA Drug Safety and Regulatory Oversight. She earned her BS in Biology from Santa Clara University, her MD from Loyola University Stritch School of Medicine, and her MPH from Johns Hopkins Bloomberg School of Public Health. She completed her internship and residency in Internal Medicine at Evanston Northwestern Healthcare. Today, this expert is...

FDA Regulation of Medical Devices Expert Witness | IllinoisView profile


FDA Regulation of Medical Devices Expert Witness | Illinois

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the...

Stephen test Amato, MBA, PhDView profile

ID: 6072898

Dr. Stephen test Amato, MBA, PhD

Dr. Stephen Amato has over 24 years of experience in Healthcare: Pharmaceuticals and Law & Legal: FDA & Drug Safety. He earned his BA in Biochemical Sciences from Harvard University, his Ph.D. in Molecular and Cellular Biology from Boston College, and his MBA in Marketing from Boston College. Today, this expert has Regulatory Affairs Certification by the Regulatory Affairs Professional Society...

Chemistry and Pharmaceuticals Expert Witness | Rhode IslandView profile


Chemistry and Pharmaceuticals Expert Witness | Rhode Island

This highly-qualified expert in chemistry and pharmaceuticals has 20 years of experience in his field. He has experience with analytical chemistry analysis, formulation chemistry, and FDA regulation, and his work has involved in all aspects of drug research and development from synthesis/purification, in-vitro, in-vivo (efficacy, pharmacokinetics and pharmacodynamics) testing, dosing routs, drug...

George CalafactorView profile

ID: 12766

Mr. George Calafactor

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...

Pharmaceutical and FDA Regulations Expert Witness | GeorgiaView profile


Pharmaceutical and FDA Regulations Expert Witness | Georgia

This expert has over 40 years of experience in the Pharmaceutical and Pharmaceutical Packaging industries. He has published five books and has instructed professionals at the graduate level in Quality Assurance and Regulatory Affairs at a major university's pharmacy school. As a former Director of the Science Branch of the Philadelphia District FDA, he directed a laboratory staff of 30 in methods...

Kevin Christopher DurandView profile

ID: 14023

Mr. Kevin Christopher Durand

This qualified expert has over 20 of experience years in the field of medical devices with an expertise in injectable drug technologies. Throughout his career, this expert has been employed by and consulted with multiple medical device and pharmaceutical companies and has gained significant experience in technological analysis, medical device engineering and manufacturing, product compliance, and...

FDA Regulations  Congressional oversight Expert Witness | WisconsinView profile


FDA Regulations Congressional oversight Expert Witness | Wisconsin

This 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...

William ZofferView profile

ID: 19708

Mr. William Zoffer

This expert has over 20 years of experience in pharmaceutical regulation and compliance. He earned his BA from Harvard College and his JD from Harvard Law School. His areas of expertise involve the regulation, compliance, governance, and enforcement of the pharmaceutical industry, including discovery, development, manufacturing, marketing, and sales. He previously served as a trial attorney for...

FDA Expert Witness | TexasView profile


FDA Expert Witness | Texas

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality...

Keith HigginsView profile

ID: 21232

Mr. Keith Higgins

This expert earned his BA in business law from Arizona State University. After graduation, he started and ran his own successful vape company for several years. In 2018, his local company was bought by a large national vape company, where he currently works as the Director of Arizona Operations.

Medical Device Regulations Expert Witness | PennsylvaniaView profile


Medical Device Regulations Expert Witness | Pennsylvania

This 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...

Gary MillerView profile

ID: 26037

Mr. Gary Miller

This highly qualified pharmaceutical safety expert earned his BS in biochemistry and molecular biology at the University of Maryland before beginning his impressive career as a pharmaceutical scientist. He formerly worked as a research scientist at Alpharma Inc, as an associate research scientist at Purdue Pharma, and as a staff scientist at Covance Laboratories. He went on to become a research...

Epidemiology, Nursing, and Medical Devices Expert Witness | MarylandView profile


Epidemiology, Nursing, and Medical Devices Expert Witness | Maryland

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...

Joseph Nicholas Ranieri, DOView profile

ID: 33241

Dr. Joseph Nicholas Ranieri, DO

This expert has over 30 years of experience in family and addiction medicine. After gaining his BS in pharmacy at Temple University School of Pharmacy, his degree in osteopathic medicine at the Philadelphia College of Osteopathic Medicine, and completing his residency in family practice at Underwood Memorial Hospital, he served as a staff physician in family practice at numerous northeastern...

Judy GanesView profile

ID: 41408

Ms. Judy Ganes

This highly-qualified expert has over 30 years of experience as a market analyst and consultant specializing in the coffee industry. She earned her BS in marketing and management at SUNY Albany and is an active member and past president of the Internation Women's Coffee Alliance. In addition, she is a member of the Specialty Coffee Association of America and the ICE Research Program. This expert...

William MeissnerView profile

ID: 43541

Mr. William Meissner

This expert has over 20 years of experience in the consumer brand industry. He earned his BS in marketing from Michigan State University and his MBA in marketing and strategy at the University of Pittsburgh. This expert has held multiple leadership roles at various food and beverage companies leading them to strategic scale. Formerly, he has served as a manager at Tetra Park, brand director at...

FDA Regulations Expert Witness FAQs

What is the role of an FDA Regulations expert witness in a legal case?

An FDA Regulations expert witness provides insight on compliance, regulatory standards, and industry practices. They can testify on violations, product safety, and approval processes.

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

Cases involving pharmaceuticals, medical devices, food safety, dietary supplements, cosmetics, or any product regulated by the FDA may require such an expert witness.

Can an FDA Regulations expert witness help with cases related to drug approval processes?

Yes. These experts can provide valuable insights into the complex process of drug approval and how deviations from this process can lead to legal issues.

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

Yes. Subspecialties can include pharmaceutical regulations, food safety standards, medical device regulations, cosmetic regulations, and more.

How can an FDA Regulations expert witness assist in a case involving adverse drug reactions?

They can evaluate whether the manufacturer complied with FDA regulations regarding reporting adverse events and if failure to comply contributed to harm.

How does Expert Institute select its FDA Regulations 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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