Expertise in all things FDA
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Expertise in all things FDA
Overview
With nearly 30 years of experience advising clients in the pharmaceutical and medical device sectors, Ms. Walsh is widely recognized as a national authority on FDA enforcement, compliance, and regulatory strategy. Her practice centers on guiding companies through the most complex and high-stakes challenges at the intersection of FDA law and government investigations.
Ms. Walsh regularly counsels clients navigating FDA inspections, warning letters, and product recalls, but her greatest strength lies in helping companies proactively prevent—or skillfully respond to—government investigations. She is a trusted advisor in high-risk matters involving the Federal Food, Drug, and Cosmetic Act, the False Claims Act, the Federal Trade Commission Act, and HHS-OIG’s exclusion authority. She has led dozens of internal investigations and negotiated successful resolutions with FDA, the Department of Justice, the U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG), and other enforcement authorities.
In a testament to her expertise and reputation, Ms. Walsh was recently selected by HHS-OIG to serve as an Independent Compliance Expert—prevailing in a highly competitive selection process. In this role, she will conduct rigorous assessments of the subject company’s compliance systems and engagements over a five-year period.
Ms. Walsh’s regulatory acumen also informs her work on corporate transactions involving life sciences companies. She leads multidisciplinary teams in conducting regulatory due diligence for mergers, acquisitions, financings, and licensing deals. She frequently advises on valuation-related risks, negotiates favorable terms, and draws upon a global network of regulatory experts to address international concerns.
Before joining Hyman, Phelps & McNamara, Ms. Walsh served as Associate Chief Counsel at FDA’s Office of Chief Counsel. Her distinguished government service was recognized with numerous awards from FDA, DOJ, HHS-OIG, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices nationwide.
Outside of work, Ms. Walsh is an avid Peloton rider (find her on the leaderboard as arlington_annie), a dedicated sports fan for professional and her daughters’ college teams, and a proud dog mom to her loyal cockapoo Cubbie.