Expertise in all things FDA
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Expertise in all things FDA
Overview
With more than 26 years of experience working with the pharmaceutical and medical device industries, Ms. Walsh brings FDA regulatory expertise to clients seeking to achieve their business objectives. She regularly counsels clients facing FDA administrative actions like inspections, warning letters, and recalls. But her passion is helping companies prevent or respond to government investigations, and she conducts internal investigations to achieve compliance and to best position her clients to defend against DOJ prosecutions. Ms. Walsh has investigated and negotiated dozens of matters involving the FDC Act, the False Claims Act, the FTC Act, or exclusion authority of the HHS Office of Inspector General.
Corporate transactions serve as a natural complement to her compliance and enforcement practice, and Ms. Walsh leverages her FDA expertise on mergers and acquisitions, financings, and licensing deals involving life sciences companies. She leads teams of attorneys within the Firm to conduct comprehensive regulatory diligence, and routinely taps into her broad network of international regulatory experts to address global concerns. She advises clients on making determinations concerning the deal and its valuation, and to negotiate favorable terms for the agreement.
Prior to joining Hyman, Phelps & McNamara, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel, and received several awards for her work from FDA, DOJ, HHS Office of Inspector General, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices throughout the country.
After hours, she can be found on the Peloton leaderboard as arlington_annie, cheering on the sidelines of her daughters’ softball games or tennis matches, or playing with her menagerie of hermit crabs, goldfish, snails, and a cockapoo.