This case involves a Food and Drug Administration (FDA) exclusivity dispute surrounding the development of a generic drug. On the same day, 2 pharmaceutical companies submitted abbreviated new drug applications for the same generic drug. An expert in FDA regulations with experience working in the office of generic drugs was sought to discuss the approval process for generics and determine the proper eligibility for generic drug exclusivity.
Question(s) For Expert Witness
1. Have you ever worked for the FDA? Please explain.
2. Can you describe your experience with FDA approval processes?
Expert Witness Response E-159741
I was the head of the chemistry division for the office of generic drugs. I also headed up their generic drug inspection program at the FDA for a time. Since then, I have held various roles at big pharmaceutical companies where I've continued to consult on processes for the FDA.
Expert Bio:
This highly qualified expert is a former FDA executive with global industry experience in product development, quality management, and regulatory compliance for drugs, biologicals, and medical devices. He earned both a bachelor's and master's in pharmacy and his PhD in pharmaceutics. Formerly, he acted as the executive vice president and general manager for the strategic regulatory division of a health technology consulting company. He had an extensive career at a large pharmaceutical company, serving as their corporate vice president for both the corporate regulatory and quality science division and the quality and regulatory division.
About the author
Victoria Negron
Victoria Negron has extensive experience in journalism and thought leadership in the legal space, with a background crafting content, whitepapers, webinars, and current event articles pertaining to the role of expert witnesses in complex litigation matters. She is a skilled professional specializing in B2B product marketing and content marketing. Currently, she serves as an Enterprise Product Marketing Manager at Postman, and previously held the position of Technical Product Marketing Manager at Palantir Technologies, where she developed her skills in launch strategies, go-to-market strategy, and competitive analysis.
Her expertise in content marketing was further refined during her tenure at the Expert Institute, where she progressed from a Marketing Writer to Senior Content Marketing Manager, and eventually to Associate Director of Content & Product Marketing. In these roles, she honed her abilities in digital marketing, SEO, content strategy, and thought leadership.
Educationally, Victoria holds a Master of Business Administration from the University of Florida - Warrington College of Business and a Bachelor of Arts in Literature, Art, and Hispanic Studies from Hamilton College. Her diverse educational background and professional experience have equipped her with a robust skill set in product marketing, content development, and strategic marketing initiatives.
