FDA Approval Expert Witnesses

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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...

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...

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...

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...

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...

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...

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...

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...

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...

FDA Approval Related Blog Posts

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

    June 29, 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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    D.C. Circuit Court Upholds FDA Regulation of E-Cigarettes

    April 5, 2021

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

    April 27, 2022

    The announcement comes just months after Bayer agreed to a $12.1 billion plan in June to settle various lawsuits it had inherited from its $63...

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    Liability Suits Filed After FDA Recall of Medtronic MiniMed Insulin Pumps

    August 26, 2021

    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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    JUUL Investors Hit with Shareholder Lawsuit

    October 15, 2020

    There appears to be no slowing down for litigation surrounding

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  • FDA Approval Expert Witness Case Studies

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    Blood Pressure Cuff Malfunction Causes Crush Syndrome

    January 7, 2022

    This case involves a case of crush syndrome resulting from continuous compression of the upper arm by a dysfunctional automatic cycle blood pressure...

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    Compounding Drug Causes Congestive Heart Failure

    January 7, 2022

    This case involves the sale of Domperidone by a pharmacist, a drug which has not been FDA approved for sale in the US, via a compounding pharmacy....

    Read more
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    Drug Manufacturer Recklessly Disregards Manufacturing Deficiencies

    January 6, 2022

    This case involves a securities class action claim against a US-based drug manufacturer. The claim focuses on the company’s failure to properly...

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    Material Science Expert Witness Opines on Faulty Knee Implant

    January 11, 2022

    This case involves a patient who suffered a serious orthopedic incident following a failure of a prosthetic knee system. The Plaintiff had the...

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    FDA Regulations Experts Weigh in On Medical Device Trademark Dispute

    January 6, 2022

    This case involves a trademark dispute between two manufacturers of consumer medical devices in Nevada. A company that offered a competing product...

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    Toxicology Expert Discusses Alleged Link Between Supplement Contamination and Autism

    January 6, 2022

    This case involves a nutritional supplement product which the plaintiff in Alaska claimed was contaminated with metallic compounds. The plaintiff...

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