Expertise in all things FDA
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Expertise in all things FDA
Overview
With nearly three decades of experience advising clients in the pharmaceutical and medical device industries, Anne Walsh is an internationally recognized authority on FDA enforcement, compliance, and regulatory strategy. Her practice focuses on guiding companies through high-stakes challenges at the intersection of FDA law and government investigations.
Anne is a go-to advisor for clients facing FDA inspections, warning letters, import detentions, and product recalls—but her greatest strength lies in helping companies proactively prevent or strategically respond to government scrutiny. She is trusted in 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, DOJ, HHS-OIG, and other enforcement agencies.
In recognition of her expertise, Anne was recently selected by HHS-OIG to serve as an Independent Compliance Expert under the terms of a Corporate Integrity Agreement—a role she earned through a highly competitive process. Over a five-year term, she will conduct rigorous assessments of a subject company’s compliance systems and engagements.
Her regulatory insight also informs her work on corporate transactions involving life sciences companies. Anne leads multidisciplinary teams in regulatory due diligence for mergers, acquisitions, financings, and licensing deals. She frequently advises on valuation-related risks, negotiates favorable terms, and taps into a global network of regulatory experts to address international concerns.
Before joining Hyman, Phelps & McNamara, Anne served as Associate Chief Counsel at FDA’s Office of Chief Counsel. Her distinguished government service earned her numerous awards from FDA, DOJ, HHS-OIG, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices nationwide.
Outside of work, Anne is an avid Peloton rider (find her on the leaderboard as arlington_annie), a devoted sports fan—cheering for both professional teams and her daughters’ college squads—and a proud dog mom to her loyal cockapoo, Cubbie.