• where experts go to learn about FDA
  • Miscellaneous

    • Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory ExpertOctober 11th, 2023

      Hyman, Phelps & McNamara, P.C. (“HP&M”), the largest FDA-dedicated law firm, is pleased to announce that Julie Beitz, M.D. has joined the firm as a Principal Drug Regulatory Expert. Dr. Beitz served in leadership positions in FDA’s Center for Drug Evaluation and Research for nearly three …

    • Hyman, Phelps & McNamara, P.C. Names Jeff Grizzel Chief Marketing OfficerSeptember 26th, 2023

      Hyman, Phelps & McNamara, P.C. (HP&M), a leader in providing legal and regulatory support to the life sciences industries, today announced the appointment of Jeff Grizzel to the newly created position of Chief Marketing Officer (CMO).  Grizzel will oversee the marketing organization, with responsibility for …

    • Fourteen HP&M Attorneys Recognized by Best Lawyers® in 2024 in AmericaAugust 25th, 2023

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is is proud to announce that 14 of the Firm’s attorneys have been selected to the 2024 edition of The Best Lawyers in America®.  Newly recognized this year are attorneys Josephine M. Torrente (FDA Law), Michelle L. Butler (FDA …

    • HP&M Attorneys Receive Accolades: Top Lawyer Under 40 and WWL: Life Sciences 2023 Global Elite Thought LeaderJune 27th, 2023

      HP&M’s James E. Valentine Named Top Lawyer Under 40; Only Food and Drug Lawyer Selected Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Law360 has recognized one of our firm’s Directors, James E. Valentine, as a 2023 Rising Star.  The honor was bestowed …

    • HP&M to Co-Chair the Host Committee for the IBA World Life Sciences ConferenceMay 25th, 2023

      ONE WEEK AWAY! Join attendees from around the globe at the IBA’s World Life Sciences Conference in Washington, DC.  We are honored to have keynote addresses from DOJ and FDA officials.  The conference will highlight hot topics affecting the healthcare and life sciences industries. Hyman Phelps …

    • HP&M’s Deb Livornese Named Volunteer of the Year for the FDA Alumni AssociationMarch 1st, 2023

      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 …

    • HPM Welcomes 15-Year DOJ Veteran, John W.M. Claud, to the FirmNovember 15th, 2022

      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 …

    • HP&M Promotes James Valentine to DirectorOctober 17th, 2022

      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 …

    • HP&M Promotes Sara Koblitz to DirectorJanuary 6th, 2022

      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 …

    • Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne LenzJanuary 6th, 2022

      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 …

    • HP&M is Pleased to Welcome Lisa Baumhardt (Senior Medical Device Regulation Expert) and Sophia Gaulkin (Associate) to the FirmNovember 17th, 2021

      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 …

    • 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 …