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概述

Elizabeth Kim counsels life sciences companies on a broad spectrum of matters related to the approval and commercialization of FDA-regulated products, including drugs, biologics, medical devices, human/nonhuman tissue products, animal health products, dietary supplements and cosmetics. 

Elizabeth has in-depth industry experience from long-term secondments and extended service as acting in-house counsel, general counsel and/or compliance officer for small and midsize manufacturers. She serves on in-house review committees to evaluate nonpromotional and promotional materials and marketing activities directed toward consumers and health care professionals. She has been involved in numerous product launches.

Elizabeth counsels clients on fraud and abuse issues; managed markets issues; and regulatory, compliance and privacy matters, and she assists with implementation of Corporate Integrity Agreements. Elizabeth advises both clients and investors on FDA-related considerations in connection with mergers and acquisitions and other types of transactions, including FDA regulatory due diligence. 

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教育背景

  • 哥伦比亚大学, M.S.
  • Rutgers University School of Law, 法学博士
  • Wellesley College, 文学学士

所属法院

  • U.S. District Court for the District of New Jersey

执业资格

  • New Jersey
  • 纽约州

承认

  • Young Lawyer Award, Rutgers School of Law, Newark, NJ (2013)

联系

  • Member, Drug Information Association
  • Faculty, Seton Hall Law Healthcare Compliance Certification Program
  • Member, Regulatory Affairs Professionals Society
  • Faculty, Lawline