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  • Hyman Phelps McNamara

    • HP&M Seeks Junior to Mid-Level Associate: Litigation/Internal InvestigationsMay 17th, 2022

      Hyman, Phelps & McNamara, P.C. (HP&M) seeks to add a 2nd to 5th year associate to its enforcement and litigation team.  Our team investigates and defends against threatened enforcement actions by government prosecutors and regulators, including the FDA and DEA.  Types of matters include: Representing clients in …

    • HP&M’s Sophia Gaulkin to Present on Drug Pricing at Advanced Summit on Life Sciences PatentsMay 5th, 2022

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be speaking on an expert panel at the 20th Advanced Summit on Life Sciences Patents, which is being held virtually and in-person in New York City on June 2-3, 2022. Ms. Gaulkin will join speakers …

    • ACI’s 17th Annual Paragraph IV Disputes Conference (In-Person and Livestream)April 14th, 2022

      The American Conference Institute (“ACI”) is hosting its 17th Annual Paragraph IV Disputes Conference in New York (and livestream) from April 26-27, 2022 (Eastern Daylight Time).  Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and …

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

    • HP&M’s Sophia Gaulkin to Present on Changes to State Drug Pricing Transparency RequirementsMarch 17th, 2022

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s Drug Pricing Transparency Congress, which is being held virtually and in-person in Philadelphia on March 28-29, 2022. Ms. Gaulkin’s presentation on Changes …

    • We are hiring! HP&M Seeks Mid-Level FDA Regulatory AttorneyJanuary 10th, 2022

      Hyman, Phelps & McNamara, P.C. is the largest dedicated FDA law firm, and we need attorneys to help our clients bring pharmaceutical drugs and medical devices to market.  Our ideal candidates have experience working at FDA (CDER, CDRH, CBER, or OCC), or have at least …

    • 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’s Adrienne Lenz to Present on Deciphering New and Proposed Regulatory Guidances for Medical Devices and DiagnosticsDecember 21st, 2021

      Hyman, Phelps & McNamara, P.C. is  pleased to announce that Adrienne Lenz will be speaking on Deciphering New and Proposed Regulatory Guidances For Medical Devices and Diagnostics at the Q1 Productions 4th Annual Life Science Regulatory Intelligence Virtual Event being held January 24-25, 2022.  The …

    • Anne Walsh to Moderate FDLI Compliance and Enforcement PanelDecember 3rd, 2021

      Hyman, Phelps & McNamara, P.C.’s Anne Walsh will be moderating “Updates in Litigation Risks: Product Liability, Private Litigation, and Consumer Class Actions,” at the upcoming Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 9-10.  As we move out of the COVID-19 …

    • 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 …

    • ABA publishes Food Law: A Practical GuideOctober 7th, 2021

      The American Bar Association has published a guide to food law that was co-authored by a number of practitioners in this growing field. The book is billed as having been “written by practicing lawyers for practicing lawyers, with a focus on information that is both …

    • ACI’s 16th Annual Paragraph IV Disputes Conference (and It’s In-Person!)September 29th, 2021

      The American Conference Institute (“ACI”) is sponsoring its 16th Annual Paragraph IV Disputes Conference on November 9-10, 2021 in New York, NY (Livestream Option Available) at the Sheraton New York Times Square Hotel.  And, unlike a lot of conferences over the past year-plus, the ACI conference format …

    • HP&M’s Jeff Shapiro and Serra Schlanger to Present on Advertising and PromotionSeptember 23rd, 2021

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15.  This conference will analyze the latest regulatory issues related …

    • ACI’s 37th Annual FDA Boot Camp (Virtual Conference)July 26th, 2021

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 37th iteration – is scheduled to take place from September 29-30, 2021 (Eastern Standard Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the …