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    • 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 …

    • HP&M Adds Two FDA Attorneys to its RanksOctober 15th, 2015

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Jenifer R. Stach and Dr. Charlene Cho have joined the firm as associates. Ms. Stach works as a general practice associate and provides counsel on regulatory matters related to foods, over-the-counter drugs, medical devices, cosmetics, …

    • The Expert Institute’s Best Legal Blog Contest: We Need Your Votes!September 10th, 2015

      The Expert Institute recently informed us that the organization is holding a “Best Legal Blog Competition” and that the FDA Law Blog has been selected to participate in the competition.  From a field of more than 2,000 potential nominees, FDA Law Blog has received enough …

    • It’s Nomination Season for the Best Legal Blogs; FDA Law Blog Needs Your Support!August 2nd, 2015

      It’s that time of year again when we ask our loyal FDA Law Blog readers for just a few minutes of their time.  You got it: it’s the best legal blog nomination season!  And this year, there are two contests for which we’re seeking your …

    • Washington DC Super Lawyers Magazine Names Five HP&M “Super Lawyers”July 15th, 2015

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that five of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2015 Washington DC Super Lawyers Magazine.  Super Lawyers is a rating service of outstanding lawyers from more …

    • ACI’s FDA Boot Camp and Paragraph IV Disputes Master SymposiumJuly 6th, 2015

      The American Conference Institute (“ACI”) will hold its 26th FDA Boot Camp conference in Boston, Massachusetts from September 30 to October 1, 2015.  A copy of the conference program can be obtained here.  Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will co-chair the event with …

    • Paralyzed Veterans Is No More. Is Auer Next?March 19th, 2015

      By Ricardo Carvajal & JP Ellison -  On March 9, the Supreme Court handed down a decision in Perez v. Mortgage Bankers Association that does away with what we’ll refer to in this posting as the Paralyzed Veterans doctrine, after an appellate court decision by that same name.  The Paralyzed Veterans doctrine …