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  • Hyman Phelps McNamara

    • ACI’s 35th FDA Boot Camp – New York EditionJanuary 31st, 2020

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY.  The conference is billed as the premier event to provide folks with …

    • HP&M’s Serra Schlanger to Present on State Drug Price Reporting LawsJanuary 24th, 2020

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020.  This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …

    • 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 …

    • HP&M Releases 2019 Enforcement BriefingJanuary 10th, 2020

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to present its annual report highlighting the leading enforcement actions from 2019 that affect the FDA- and DEA-regulated industries.  As the largest boutique law firm dedicated to serving clients in this field, we are keenly aware of …

    • HP&M Attorney Co-Authors Nature Reviews Article with NIH, FDA, and EMA on the Progress and Challenges of Drug Development for Rare DiseasesDecember 19th, 2019

      On December 13, 2019, Nature Reviews Drug Discovery published an article that reviews the landscape of the development of drugs for rare diseases, both the progress and challenges.  The article was authored by HP&M Attorney James E. Valentine along with co-authors from the BioPontis Alliance …

    • 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 …

    • FDA Law Alert – November 2019November 6th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish the third installment of the FDA Law Alert, a quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and …

    • HP&M Attorneys Recognized by LMG Life Sciences AwardsSeptember 20th, 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 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 …

    • FDA Law Alert: Issue #2August 7th, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to publish this second issue of the FDA Law Alert, a newsletter highlighting key postings from our nationally acclaimed FDA Law Blog.  Please subscribe to the FDA Law Blog to receive contemporaneous posts on government regulatory and enforcement …

    • ACI’s Paragraph IV Disputes Master SymposiumAugust 7th, 2019

      The American Conference Institute’s (“ACI’s”) popular “Paragraph IV Disputes Master Symposium” is coming up again! The conference will take place from October 3-4, 2019 at the W Chicago in City Center, Chicago, IL. ACI has put together an excellent program for conference attendees that include presentations …

    • ACI’s 34th FDA Boot Camp – Boston EditionJuly 24th, 2019

      The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 34th iteration – is scheduled to take place from September 18-19, 2019 at The Bostonian Hotel, Boston, MA. The conference is billed as the premier event to provide folks with a roadmap …

    • 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 …