Speaker details

Biography

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 advises clients in M&A transactions requiring FDA expertise. She leads teams of attorneys to conduct comprehensive FDA-related diligence, and to advise clients on making determinations concerning the deal and its valuation. She also regularly counsels clients on managing FDA inspections, responding to warning letters, and deciding when to submit mandatory reports or conduct recalls. She has specific expertise in matters involving alleged FDC Act violations, such as off-label promotion or inadequate manufacturing practices. Prior to joining HPM, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel.