Danielle C. Humphrey
Danielle C. Humphrey understands the pressures businesses face in the highly regulated life science industry. A former Assistant General Counsel of Wal-Mart Stores, Inc., she uses her experience in the industry and firm grasp of medical device law and regulation to help yield innovative and practical solutions for her clients.
Danielle focuses on matters related to advertising and promotion, regulatory compliance, and premarket clearance and approval of new medical devices and combination products. She advises clients on the U.S. Food and Drug Administration's (FDA) regulation of medical devices and combination products.
She analyses complex legal challenges and regulatory strategy for innovative products, prepares regulatory submissions, reviews print and web-based promotional and educational materials, reviews company-wide regulatory audits, and reviews and drafts standard operating procedures. Danielle also reviews and negotiates contracts. She assists in the defense of criminal investigations by the U.S. Department of Justice, responding to FDA Warning Letters and Form 483s. She conducts regulatory due diligence and assists in negotiating corporate mergers and acquisitions and initial public offerings. While in law school, Danielle was a member of the Duke Law Mock Trial Board and editor for Law and Contemporary Problems, an interdisciplinary journal published by Duke Law School that focuses on the intersection of science, social sciences, humanities, and law.
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03 November 2016