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    • Festivus for the Rest of Us: How Competitors Can Air Grievances with the New AdministrationNovember 20th, 2020

      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 …

    • HP&M Announces that Sara Koblitz has been Promoted to Counsel at the FirmNovember 18th, 2020

      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, …

    • HP&M Takes Home “Law Firm of the Year” Award from U.S. News and Best LawyersNovember 13th, 2020

      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 …

    • Navigating Corporate Social Responsibility ClaimsOctober 26th, 2020

      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 …

    • How to Stay In Touch With Your Customers During the Coronavirus PandemicSeptember 14th, 2020

      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 …

    • HP&M is Pleased to Welcome Karin Moore to the Firm as a DirectorFebruary 12th, 2020

      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 …

    • Richard Lewis Joins HP&M as Senior Regulatory Device & Biologics ExpertFebruary 12th, 2020

      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 …

    • HP&M is Pleased to Welcome Gail Javitt to the Firm as a DirectorJanuary 17th, 2020

      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 …

    • HPM Congratulates Two New Directors, Deborah L. Livornese and Serra J. SchlangerDecember 4th, 2019

      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 …

    • HP&M Takes Home Tier 1 FDA Law Ranking Honors from U.S. News and Best LawyersNovember 13th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …

    • HP&M is Pleased to Welcome Suchira Ghosh to the FirmAugust 20th, 2019

      Hyman, Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Suchira Ghosh has joined the firm as Counsel.  Suchira comes to HP&M with more than 10 years of FDA and Hatch-Waxman legal experience, as well as several years of experience working as a process …

    • Join Our Team: HPM Seeks Junior to Mid-Level AssociateJune 3rd, 2019

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate.  A demonstrated interest in food and drug law and regulation is preferred; strong research and writing skills are required.  Compensation is competitive and commensurate …

    • Upcoming Conference on Digital Health Regulatory IssuesApril 1st, 2019

      The Food and Drug Law Institute (FDLI) is holding a conference devoted to digital health regulatory issues:  Medical Devices: FDA Regulation in the Era of Technology and Innovation. Hyman, Phelps & McNamara’s Jeffrey K. Shapiro is the Chair.  The conference will be held in South …

    • FDA Commissioner Scott Gottlieb Announces His ResignationMarch 7th, 2019

      On March 5, Scott Gottlieb, M.D., announced he will be stepping down as Commissioner of FDA.  His resignation will become effective in about one month.  His two-year tenure, since May 2017, has been very productive.  Gottlieb spearheaded initiatives on a variety of complex issues, including …

    • HP&M’s Hatch-Waxman Practice Grows With the Addition of Michael ShumskyFebruary 8th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Michael Shumsky has become its newest Director.  Mike joined HP&M in February 2019 after nearly 15 years at Kirkland & Ellis LLP, where he played a key role in developing that firm’s FDA and …