Global law firm K&L Gates LLP welcomes Erica M. Jackson as an FDA partner in its Research Triangle Park office. Jackson joins the firm from Genentech, Inc., where she served as corporate regulatory counsel for the California-based biotechnology company.
Jackson will focus her practice on Food and Drug Administration (FDA) regulatory matters, providing strategic counsel to pharmaceutical, medical device, dietary supplement, food, and biotechnology companies, as well as other related health care entities. She will advise clients on issues related to compliance with laws and regulations enforced by the FDA, the Drug Enforcement Administration (DEA), the Federal Trade Commission (FTC), the Centers for Medicare and Medicaid Services (CMS), the U.S. Department of Agriculture (USDA), and similar state regulatory agencies.
With an educational background in both law and public policy/health, Jackson’s capabilities comprise various aspects of FDA compliance in the life sciences space, from pre-clinical/clinical development to post-marketing promotional and manufacturing matters. She also has experience with FDA-related contractual and transactional negotiations, global clinical trials, fraud and abuse compliance, and resolving FDA enforcement actions.
“Our U.S. FDA practice will immediately benefit from Erica’s experience and in-depth knowledge on FDA legal and regulatory issues, particularly in the pharmaceutical and biologic space,” said Mary Beth F. Johnston, a co-leader of K&L Gates’ health care and FDA practice and administrative partner of the firm’s Research Triangle Park office. “We look forward to working with her to offer our FDA-regulated clients informed and innovative legal solutions to a variety of government and transactional issues.”
Lawyers in K&L Gates’ FDA practice counsel clients, including pharmaceutical, biologic, medical device, dietary supplement, food additive, cosmetic, and tobacco product manufacturers, pharmacies, and clinical investigators, on a variety of state and federal regulatory and compliance issues affecting pre-market approval and post-marketing compliance issues.
Jackson’s addition follows the arrival of health care public policy partner Amanda Makki in Washington, D.C., earlier this month.
Source: www.klgates.com
