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    • ACI’s 28th FDA Boot CampAugust 2nd, 2016

      The American Conference Institute’s (“ACI”) popular FDA Boot Camp, now in its 28th iteration, is slated to take place at the Omni Parker House in Boston, Massachusetts from September 22-23, 2016. The conference is billed as the premier event to provide folks with a roadmap …

    • International Pharmaceutical Supply Chain Imperiled Like Never Before: A Webinar SummaryJune 30th, 2016

      In recent years, the level of scrutiny of foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand for and dependence of Western countries on the supply of goods coming from those facilities.  A recent webinar, International Pharmaceutical Supply Chain Imperiled …

    • HP&M Seeks Junior to Mid-Level AssociateJune 22nd, 2016

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice.  Strong verbal …

    • Reminder: International Pharmaceutical Supply Chain Imperiled Like Never Before – A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara PCJune 16th, 2016

        In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …

    • Join Our Team – HP&M Seeks Junior to Mid-Level AssociateJune 6th, 2016

      Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks a junior to mid-level associate with substantive experience in medical devices and other areas of food and drug law and regulation to assist with a growing practice.  Strong verbal …

    • International Pharmaceutical Supply Chain Imperiled Like Never Before: A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara PCJune 2nd, 2016

        In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled …

    • HP&M Publishes Comprehensive Deskbook on FDA Compliance and EnforcementMay 16th, 2016

      The FDA Law Blog is pleased to announce the release of the FDA Deskbook, prepared by the attorneys at Hyman, Phelps & McNamara, P.C., the same authors who provide the expertise and analysis contained in this blog.  The FDA Deskbook is a complete resource on …

    • HP&M to Highlight its New FDA Deskbook on Compliance and EnforcementApril 19th, 2016

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is proud to announce the publication of its FDA Deskbook, incorporating more than a century of experience of HP&M’s attorneys from positions in the government and regulated industry. The FDA Deskbook provides a comprehensive resource that details the ins-and-outs …

    • Drug Promotion in the 21st Century: Off-label Marketing and First Amendment ConcernsMarch 23rd, 2016

      On March 31, 2016, from 10:00 AM – 12:30 PM, the American University Washington College of Law (Washington, D.C.) will hold a symposium to discuss recent developments in off-label promotion, including the recent Amarin case (see our previous post here).   The symposium, titled “Drug Promotion …

    • HP&M’s John Fleder, Dara Katcher Levy, and James Valentine to Speak at DIA’s Marketing Pharmaceuticals 2016February 29th, 2016

      DIA is holding its 27th annual Marketing Pharmaceuticals conference on Thursday and Friday, March 3-4, 2016, at the Bethesda North Marriott Hotel and Conference Center in Bethesda, MD. DIA is a not-for-profit, global organization dedicated to bringing health care product development professionals together in a …

    • International Pharmaceutical Supply Chain Imperiled Like Never BeforeFebruary 29th, 2016

      Over the past few years, the Food and Drug Administration has dramatically increased its inspections of foreign manufacturing facilities for Active Pharmaceutical Ingredients (APIs) and finished dosage form drugs, with potentially cataclysmic consequences for U.S. parent companies, distributors, and manufacturers relying on foreign APIs or …

    • HP&M Announces Addition of New Of Counsel: Mark I. SchwartzJanuary 10th, 2016

      Hyman Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Mark I. Schwartz has joined the firm as Of Counsel. Mr. Schwartz advises clients on biologic, drug, and device compliance, as well as on regulatory issues. He joined the firm after spending close to …

    • HP&M Announces Addition of New Of Counsel to its RanksDecember 15th, 2015

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Melisa M. C. Moonan has joined the firm as Of Counsel. Ms. Moonan advises clients on medical device regulatory issues. She joined the firm after close to six years as Associate Chief Counsel for Regulatory …

    • FDA Law Blog is Tapped for the ABA Journal’s Blawg 100 – Our 5th Time!November 24th, 2015

      Earlier this week we received an email from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected to the 2015 (and 9th annual) ABA Blawg 100.  The Blawg 100 is a list of …

    • Just One Letter Off: HP&M’s Karla Palmer to Speak at FBA Annual Litigation ConferenceOctober 26th, 2015

      Join the Federal Bar Association (FBA) and its Federal Litigation Section on Tuesday, October 27 in Washington, DC for the Annual FBA Federal Litigation Conference! Expert panelists and judges will be discussing hot topics including but not limited to cyber security, electronic evidence, and tips …