The FDA Alumni Association (FDAAA) named Hyman, Phelps & McNamara, P.C.’s Director Deb Livornese as its 2022 Volunteer of the Year for her remarkable leadership steering its Activities Committee through COVID and many new challenges. The FDAAA, whose members are FDA alumni and current employees, helps …
Hyman, Phelps & McNamara, P.C. (“HPM”) is pleased to announce that John W.M. Claud has joined the firm as Counsel. Mr. Claud is a 15-year veteran of the Department of Justice, where most recently he was an Assistant Director of the Consumer Protection Branch overseeing …
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that James E. Valentine will become the firm’s newest Director beginning on January 1, 2023. James’s practice focuses on regulatory considerations for developing new drug and biologic products and FDA regulatory requirements for approval/licensure. James has been …
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director. Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the …
Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce Adrienne R. Lenz has become its first Principal Medical Device Regulation Expert. Adrienne joined HPM in September 2017. In her time with HPM, she has made significant contributions to the firm and its clients. Prior to joining …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Lisa M. Baumhardt, MS, MJ, MT(ASCP), RAC, FRAPS, has joined the firm as a Senior Medical Device Regulation Expert, and that Sophia Gaulkin has joined the firm as an Associate. Ms. Baumhardt provides counsel to …
A new administration always brings with it the excitement of new political appointees, briefing books and never-ending speculation about forthcoming changes in the direction of various agencies. It also brings the opportunity for meetings with incoming government officials for an airing of the grievances. While …
Hyman Phelps & McNamara, P.C. is pleased to announce that Sara Koblitz has been promoted to Counsel at the firm. Sara joined HPM in 2017 and advises clients on a broad range of FDA regulatory issues with a particular focus on Hatch-Waxman patent and exclusivity, biosimilars, …
Hyman, Phelps & McNamara, P.C. (“HP&M”) has been named the FDA Law “Law Firm of the Year” by the folks over at U.S. News & World Report, who teamed up with Best Lawyers for the 2021 “Best Law Firms” rankings. We’re truly honored! But the honors …
Companies are embracing corporate social responsibility (CSR) more and more; it is a way for companies and brands to incorporate the company’s values into their business model, and engage with customers and employees on a different level. It is not without risk, however, and our …
On Tuesday, September 15, at 8:00 am, Hyman,Phelps & McNamara, P.C. Director Gail Javitt will moderate a one hour webinar sponsored by the Maryland Israel Development Center (MIDC), titled “How to Stay In Touch With Your Customers During the Coronavirus Pandemic.” The webinar will feature …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director. Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert. Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Gail Javitt has become its newest Director. Many leading companies have turned to Gail for her deep knowledge, skills, experience and thought leadership on the complex regulatory issues they face while looking to innovate …
Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce that Deborah L. Livornese and Serra J. Schlanger have become its newest directors. Deborah’s practice covers a broad range of FDA regulatory issues. She assists pharmaceutical drug companies of all sizes on drug development and regulatory …
