Lisa Harrington

Hyman, Phelps & McNamara, P.C. is hosting a free webinar on recent and forward-looking enforcement under the Federal Food, Drug & Cosmetic Act on Thursday, May 1, 2025, from 12:00 p.m. to 1:30 p.m. (ET) (register here). Join us as HPM’s Anne Walsh moderates a panel discussion with three …

Hyman, Phelps & McNamara (HPM) marks its 45th Anniversary year by welcoming three accomplished professionals who reinforce the depth and breadth of the firm’s FDA and DEA practices. Naomi Lowy joins HPM as a Principal Drug Regulatory Expert after 18 years at the FDA’s Center for Drug …

Anne Walsh is quoted in this article

Washington, D.C., March 5, 2025 – Hyman, Phelps & McNamara, P.C. is pleased to announce the return of Andrew Hull to the firm, bringing with him invaluable experience gained over the past six years as federal Department of Justice (DOJ) prosecutor investigating and litigating cases …

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Hyman, Phelps & McNamara PC, (HPM), which will mark its 45th Anniversary on March 17, 2025, is pleased to announce that it is increasing its directors, counsel, and associates as it starts the year. Kalie E. Richardson has been promoted to Director. Mark Tobolowsky has been promoted to …

Inspection authority is one of the most valuable tools the FDA has to create its gold-standard culture of safety and efficacy. No drug or device maker is happy to see FDA when they come calling to scrutinize operations, but every consumer of their products demands …

To borrow (at least in part) from Shakespeare, “FDA doth protest too much, methinks” when it comes to its proposed rule that would impose more stringent regulatory controls of wound products. These protestations begin with FDA maintaining that wound products with antimicrobials may contribute to …