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  • Hyman Phelps McNamara

    • Telemedicine: Understanding FDA’s Role in Recent Regulatory and Enforcement ActionsJuly 12th, 2019

      Telemedicine platforms provide consumers and patients with convenient access to healthcare services. For this reason, the interest in and use of telemedicine services has increased significantly in recent years. While many discussions of the risks related to telemedicine focus on state laws and fraud and abuse concerns, …

    • Hyman, Phelps & McNamara, P.C. is Hiring!June 24th, 2019

      The authors of this blog are busy, and we are actively seeking attorneys interested in working at the nation’s largest boutique food and drug regulatory law firm (and ideally writing for the FDA Law Blog).  We have at least two openings: The first position is for …

    • ACI’s Annual Legal, Regulatory & Compliance Forum on Dietary SupplementsJune 3rd, 2019

      The American Conference Institute (“ACI”), together with the Council for Responsible Nutrition, are sponsoring ACI’s  Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements. The conference is scheduled to take place at the InterContinental New York Times Square in New York, New York from June …

    • 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 …

    • ACI’s 13th Annual Paragraph IV Disputes ConferenceMarch 26th, 2019

      Spring is here!  How do we know?  Is it the cherry blossoms starting to bloom in Washington, DC?  Is it the daffodils emerging from hibernation?  No – we know it’s Spring because the annual American Conference Institute (“ACI”) “Paragraph IV Disputes” conference is right around …

    • ACI’s 33rd FDA Boot Camp – New York City EditionMarch 8th, 2019

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 33rd iteration – is scheduled to take place from March 25-27, 2019, at the Park Lane Hotel in New York, NY. The conference is billed as the premier event to provide folks …

    • Telemedicine Lunch-and-Learn at HP&MFebruary 25th, 2019

      Hyman, Phelps & McNamara, P.C. (HP&M) is proud to announce that two associates, Serra Schlanger and Rachael Hunt, will be hosting a program on telemedicine for FDLI’s New to Food and Drug Law Group (NFDL). Telemedicine: Key Issues to Consider When Advising Clients, will take place …

    • 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’s Anne Walsh to Present on Pharmacovigilance & Drug Safety IssuesJanuary 31st, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019.   The focus of her presentation is on post-market …

    • FDLI to Sponsor Webinar on Patient Assistance ProgramsJanuary 28th, 2019

      Next Thursday, February 7, the Food and Drug Law Institute will conduct a webinar entitled, “Patient Assistance Programs, Recent Enforcement and Best Practices.”  The webinar will cover the various forms of patient assistance programs, the legal authorities that apply to them, recent enforcement actions, best …

    • CBI’s 4th Edition Drug Pricing Transparency CongressJanuary 23rd, 2019

      CBI is holding its Fourth Edition Drug Pricing Transparency Congress on March 25-26, 2019 in Philadelphia, Pennsylvania.  This program convenes stakeholders to discuss how the future of drug pricing transparency regulations will impact commercialization, reimbursement, pricing, and compliance practices.  Given the novelty and complexity of …

    • HP&M Releases 2018 Litigation BriefingJanuary 9th, 2019

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading cases and settlements from 2018 that affect the FDA- and DEA-regulated industries. Each page provides a concise summary of the relevant facts and key takeaways for our clients. We …

    • Congratulations to HPM’s Newest Director, Allyson MullenJanuary 7th, 2019

      Hyman, Phelps & McNamara, P.C. (HPM) is pleased to announce Allyson B. Mullen has become its newest Director.  Allyson joined HPM in June 2013.  Since that time, her years of service have made significant contributions to the firm and its clients. Prior to joining HPM, Allyson served …

    • FDLI’s Drug Quality Security Act ConferenceOctober 22nd, 2017

      The Food and Drug Law Institute’s (“FDLI”) Drug Quality and Security Act (“DQSA”) conference is just a few weeks away, and spaces are going fast! The conference will be held on November 15, 2017, in Washington, D.C. Hyman, Phelps & McNamara, P.C.’s Karla L. Palmer …