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 …
March 20, 2024 Hyman, Phelps & McNamara, P.C. (HP&M), the largest dedicated food and drug law firm in the U.S., is pleased to announce that Director Allyson Mullen has been appointed to the Board of Directors of the Association of Medical Diagnostic Manufacturers (AMDM). This prestigious appointment recognizes Ms. Mullen’s …
For over a decade, the Food and Drug Administration (FDA) has devoted extensive resources to banning the use of an FDA-cleared medical device that is being successfully used by medical doctors and other licensed health care professionals at one facility to treat approximately 50 patients …