FDA Approval Expert Witness

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 hospitals and clinical practices. He is board certified in both family ...

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 scientist and a scientist III at Actavis. Finally, he worked as a senior ...

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....

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 the US Department of Justice and as the senior vice president of ...

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 testing and investigation. Currently, this expert is the president and ...

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 investigator. He has served as a consultant of medical device regulation ...

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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 and Private Pilot License by the Federal Aviation Administration. He is also ...

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 board-certified in Internal Medicine by the American Board of Internal Medicine. ...

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 Albert Abramson ’54 Distinguished Professor of Law Chair, and as an Arthur J. ...

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 PepsiCo/SoBe, and chief marketing officer for Fuze Beverages. This expert then ...

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 regularly contributes articles to industry publications such as Coffee and ...