Speaker details

Biography

With more than 27 years of experience in private practice and government, 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.