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Generic Drug Labeling Proposed Rule and Safety Updates

Speakers

Ethel  Holtzclaw

Ethel Holtzclaw

Regulatory Affairs Manager, Pharmalink Consulting, United States

Michael  Swit, JD

Michael Swit, JD

Senior Director, Legal, Regulatory Affairs, Varian, United States

MICHAEL SWIT has been solving vital legal and regulatory issues since 1984. Before relaunching his FDA law practice in 2017, he served for three years at Illumina, the leader in gene sequencing technology, as its chief regulatory counsel. Prior to that, Swit was in the FDA Law Practices at three global law firms, served as a vice president at The Weinberg Group, a premier regulatory consultancy, and was general counsel of Par Pharmaceutical, a major generic drug maker. He earned his AB, magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University

Gary L Yingling, JD

Gary L Yingling, JD

Senior Counsel, Wiley Rein LLC, United States

Gary Yingling is a partner with K&L Gates. His practice focuses on regulatory and legal issues concerning food, drugs, medical devices and cosmetics. He works primarily with FDA, but also represents clients before the USDA Food Safety & Inspection Service, EPA, CPSC, the FTC, and various states.

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