News

  • HP&M Director, Allyson Mullen, Appointed to the Association of Medical Diagnostic Manufacturers 2024-2026 Board of DirectorsMarch 27th, 2024

    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 …

  • Hyman, Phelps & McNamara, P.C. Takes Top Honors in Two Prestigious Categories in 2023 LMG Life Sciences AwardsNovember 7th, 2023

    WASHINGTON, DC — Hyman, Phelps & McNamara, P.C. is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, …

  • Senior FDA Official Dr. Julie Beitz Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory ExpertOctober 16th, 2023

    October 11, 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 …

  • Hyman, Phelps & McNamara Names Jeff Grizzel Chief Marketing OfficerSeptember 25th, 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

    August 25, 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 Law), Sara W. …

  • James R. Phelps: 1938 – 2022April 4th, 2022

    April 4, 2022 With great sadness, we announce that our firm’s co-founder, leader, colleague and friend, Jim Phelps passed away on April 2, 2022, at the age of 83. Jim is survived by Sophia, his wife of 57 years, his three sons and their wives, Evan …

  • Former FDAer Dr. Ellis F. Unger Joins Hyman, Phelps & McNamara, P.C. as Principal Drug Regulatory ExpertFebruary 24th, 2022

    Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased and excited to announce that Dr. Ellis F. Unger has joined the firm as a Principal Drug Regulatory Expert.  Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of …

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

    January 6, 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 …

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

    January 6, 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 …

  • 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, and the …

  • 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 …

  • HP&M is Pleased to Welcome Gail Javitt to the Firm as a DirectorJanuary 24th, 2020

    January 17, 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 …

  • HP&M Attorneys Recognized by LMG Life Sciences AwardsSeptember 23rd, 2019

    Awards season is now underway and we are delighted to announce that LMG Life Sciences has named Josephine Torrente the 2019 “Regulatory Attorney of the Year: FDA Pharmaceuticals.” Now in its seventh year, the LMG Life Sciences Awards are presented to the firms and individuals “behind …

  • 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 …

  • HP&M Snags Another Award: LMG Life SciencesNovember 16th, 2018

    As 2018 winds down, awards season is in full swing! Last week we announced that Hyman, Phelps & McNamara, P.C. (“HP&M”) was tapped by U.S. News and Best Lawyers as the recipient of the 2019 “Law Firm of the Year in FDA Law” award.  This …

  • HP&M Takes Home 2019 “Law Firm of the Year in FDA Law” Honors from U.S. News and Best LawyersNovember 16th, 2018

    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 Director Larry Houck Receives NASCSA President’s AwardNovember 14th, 2018

    During the 34th annual National Association of State Controlled Substances Authorities (“NASCSA”) conference in Scottsdale, Arizona, Hyman, Phelps & McNamara, P.C. (“HP&M”) Director Larry Houck was honored with the organization’s 2018 President’s Award. NASCSA provides a forum for state, federal and local regulators, healthcare professionals, …

  • U.S. News and World Report Ranks HPM as Top Tier FDA Law FirmDecember 13th, 2013

    For the fourth year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of FDA Law (both nationally and in Washington DC) by the folks over at U.S. News & World Report, who teamed …

  • Jeff Gibbs honored with FDLI Distinguished Service and Leadership AwardDecember 10th, 2013

    Jeff Gibbs was honored when The Food and Drug Law Institute (“FDLI”) awarded him with the 2013 Distinguished Service and Leadership Award. The award is given each year to as many as four individuals from various areas of the food and drug law community …

  • Former Novo Nordisk General Counsel James C. Shehan Joins the firmNovember 11th, 2013

    Hyman, Phelps & McNamara, P.C. is pleased to announce that James C. Shehan has joined the firm as Of Counsel. Previously, Mr. Shehan served for 19 years as Novo Nordisk Inc.’s General Counsel and Corporate Vice President of Legal, Government and Quality. His …

  • Former White House Fellow Kermit L. Jones joins the firmOctober 1st, 2013

    Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …

  • A Three-peat: U.S. News and World Report Ranks HPM as Top Tier FDA Law FirmOctober 24th, 2012

    For the third year in a row, Hyman, Phelps & McNamara, P.C. has been ranked as a “Tier 1” law firm in the area of “FDA Law” by the folks over at U.S. News & World Report, who once again teamed up with Best Lawyers …

  • Drug Regulation DVDs AvailableMarch 22nd, 2011

    HPM and Virginia Tech are pleased to announce the availability of the first two DVDs of the VERSUS series that is being sponsored by the University. They provide an overview of the processes a prescription drug must follow to be approved by the United States …

  • HPM Calls On FDA to Post on the Internet All Court Filings Regarding Enforcement ActionsMarch 11th, 2011

    On January 18, 2011, the President issued a significant Order entitled a “Memorandum for the Heads of Executive Departments and Agencies.” The Memorandum directs “agencies with broad regulatory compliance and administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning …

  • Firm Announces New Director and Of CounselNovember 15th, 2010

    Hyman, Phelps & McNamara, P.C. is very pleased to announce that Ricardo Carvajal has been named Director of the firm, and that Dara Katcher Levy has been named Of Counsel. Mr. Carvajal’s practice focuses on providing FDA and FTC regulatory counseling and litigation support …

  • U.S. News & World Report Ranks HPM as Top Tier FDA Law FirmSeptember 20th, 2010

    Hyman, Phelps & McNamara, P.C. is proud to announce that the inaugural “Best Law Firms” survey by U.S. News & World Report has ranked HP&M as a “Tier 1” law firm in the area of FDA Law. Only six firms made it to the …

  • HPM Announces New Director and AssociateMay 11th, 2007

    Hyman, Phelps & McNamara, P.C. is very pleased to announce that Jeffrey K. Shapiro has joined the firm as a director and Carrie S. Martin has joined the firm as an associate. Prior to joining the firm, Mr. Shapiro was a partner at Hogan & …

  • HPM Celebrates Its 25th AnniversaryMarch 17th, 2005

    March 17, 2005 marked the 25th anniversary of the date the firm opened its doors for business. To commemorate the occasion, HPM employees celebrated with a formal dinner and dance at the National Museum of Women in the Arts.