EXPERT WITNESS SPECIALTY INDEX

FDA Regulations Expert Witnesses

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Pharmaceutical and FDA Regulations Expert Witness | GeorgiaView profile

E-007167

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...

Forensic Legal Analysis Expert Witness | GeorgiaView profile

E-006733

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...

FDA Regulations  Congressional oversight Expert Witness | WisconsinView profile

E-074885

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...

FDA Expert Witness | TexasView profile

E-015772

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...

Medical Device Regulations Expert Witness | PennsylvaniaView profile

E-511302

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...

FDA Regulation of Medical Devices Expert Witness | IllinoisView profile

E-611415

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...

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

E-663217

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...

Chemistry and Pharmaceuticals Expert Witness | Rhode IslandView profile

E-528687

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...

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...

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...

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...

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...

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...

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...

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.

FDA Regulations Posts

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    Zantac MDL Judge Finds Preemption for Economic Injury, Design Defect Claims

    Published on - February 19, 2021

    In early January 2021, U.S. District Court Judge Robin Rosenberg moved to dismiss economic damages and design defect claims against major drugmakers...

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    House Oversight Committee Finds Popular Baby Food Brands Contain High Levels of Toxic Metals

    Published on - February 10, 2021

    The House Committee on Oversight and Reform recently released a report showing that seven popular brands of baby foods are contaminated with toxic...

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    D.C. Circuit Court Upholds FDA Regulation of E-Cigarettes

    Published on - December 10, 2020

    The regulation of electronic cigarettes—often called e-cigarettes—has yet again come before the federal appeals court. Last week, a unanimous panel...

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    JUUL Investors Hit with Shareholder Lawsuit

    Published on - October 15, 2020

    There appears to be no slowing down for litigation surrounding JUUL, the electronic cigarette company named in a flurry of lawsuits in the past few...

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    Bayer to Pay $1.6 Billion to Settle Defective Essure Contraceptive Device Lawsuits

    Published on - September 24, 2020

    The latest in an eventful year for Bayer Pharmaceuticals is a $1.6 billion settlement to resolve claims against its Essure contraceptive device.

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    Liability Suits Filed After FDA Recall of Medtronic MiniMed Insulin Pumps

    Published on - September 8, 2020

    The Class I recall, the most serious type of FDA recall, announced the regulatory agency’s discovery that the insulin pumps were incorrectly dosing...

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  • Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme

    Pharmaceutical Company Allegedly Involved In Opioid Kickback Scheme

    Published on - October 30, 2018

    This case involves the alleged improper marketing of a particular opioid pain medication by a defendant pharmaceutical company. The allegations...

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  • Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

    Manufacturer Is Accused Of Mislabeling Over-The-Counter Products

    Published on - December 11, 2018

    This case involves a distribution rights dispute between a skincare products company and another member of their LLC. The defendant company had...

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  • FDA Expert Reviews Regulatory Hip Replacement Violations

    FDA Expert Reviews Regulatory Hip Replacement Violations

    Published on - March 26, 2019

    This case involves a hip replacement device MDL. It was alleged that the device manufacturer did not provide proper adverse event reports to the FDA...

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  • Insufficient Pre-Market Screening Allegedly Causes Pelvic Medical Device Failure
  • FDA Expert Opinion Irrelevant To Breach of Warranty Discussion In Medical Device Class Action
  • Court Finds Combined Consideration Hinders Relevance of Expert Testimony in Risperdal Gynecomastia Cases
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