• where experts go to learn about FDA
  • Miscellaneous

    • HP&M Mourns the Loss of a Good Friend and ColleagueFebruary 2nd, 2015

      Attached here is the obituary of Frank Hurley, as issued by his company RRD International.  Frank was a Co-Founder of RRD as well as its Chairman and Chief Scientific Officer.  The obituary’s rich detail correctly describes his professional reputation as the premier innovator in his …

    • FDA’s Office of Generic Drugs Finally Has a Permanent Captain; Kathleen “Cook” Uhl, M.D., Named Permanent DirectorJanuary 15th, 2015

      By Kurt R. Karst –        The news came down on Thursday that FDA’s Center for Drug Evaluation and Research Director Janet Woodcock, M.D., named Kathleen “Cook” Uhl, M.D., as the permanent director of the Office of Generic Drugs (“OGD”).  Although Dr. Uhl has manned the helm at OGD …

    • A Double-Repeat! FDA Law Blog Once Again Makes the ABA Journal’s Blawg 100December 3rd, 2014

      While we were busy preparing for our Thanksgiving holiday last week, we received the email we had been hoping for: a congratulatory email from the editors of the American Bar Association (“ABA”) Journal announcing that Hyman, Phelps & McNamara, P.C.’s FDA Law Blog was selected …

    • U.S. News & World Report Once Again Ranks HP&M as Top Tier FDA Law Firm; LMG Life Sciences Gives Us a Thumbs-UpNovember 10th, 2014

      Hyman, Phelps & McNamara, P.C. 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 for …

    • ACI’s 23rd FDA Boot CampJuly 30th, 2014

      The American Conference Institute’s popular FDA Boot Camp, now in its 23rd iteration, is slated to take place at the Omni Parker House Boston in Boston, MA from Thursday, September 18 to Friday, September 19, 2014.  The conference is billed as the premier event to …

    • The 2014 ABA Blawg 100 – Our Best Arnold Horshack Plea for NominationsJuly 11th, 2014

      It’s July, and that means the American Bar Association (“ABA”) has initiated the annual process for selecting the top legal blogs (or “blawgs”) in the blogosphere.  The 8th iteration of the list will be revelaed later this year when the ABA announces the “Blawg 100” …

    • Senate HELP Committee Asks FDA to Explain its Use of Draft GuidancesMay 7th, 2014

      By Jeffrey N. Wasserstein – We have previously noted that FDA has increasingly regulated through issuance of guidance documents – rather than through notice-and-comment rulemaking as required by the Administrative Procedure Act.  The U.S. Senate Committee on Health, Education, Labor, and Pensions (the Senate HELP Committee) …

    • Washington DC Super Lawyers Magazine Names Six HP&M “Super Lawyers”April 30th, 2014

      Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that six of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2014 Washington DC Super Lawyers Magazine.  Super Lawyers is a rating service of outstanding lawyers from more …

    • Game On! The HP&M Crossword PuzzleMarch 26th, 2014

      Earlier this week we gave a “Coming Soon” announcement about a forthcoming posting of an FDA-related crossword puzzle written by Jeffrey N. Gibbs and Etan J. Yeshua as part of a celebration of Hyman, Phelps & McNamara, P.C.’s 34th anniversary earlier this month.  Well, it’s here …

    • Coming Soon: The HP&M Crossword PuzzleMarch 23rd, 2014

      (In our best Don LaFontaine voice) IN A WORLD where food and drug attorneys and regulatory professionals are all work and no play, there’s something coming to relieve the monotony and to spice up your work life.  That’s right, after a very, very long hiatus, our “Lighter Side …

    • FDLI’s Winckler to Step Down as President and CEO; Search UnderwayMarch 20th, 2014

      The Food and Drug Law Institute (“FDLI”) recently announced that President and Chief Executive Officer Susan C. Winckler will step down from that position effective May 23, 2014.  Ms Winckler, a pharmacist and attorney, was named to the position in November 2009.  She previously served …

    • DOJ Seeks Injunctive Relief Against Toy and Children’s Products CompaniesFebruary 25th, 2014

      By JP Ellison – On February 24, 2014, the U.S. Department of Justice announced a civil lawsuit and partial settlement arising out of alleged violations of statutes enforced by the Consumer Product Safety Commission (the “CPSC”). According to the press release, the complaint alleges that four California companies …

    • HP&M Honors: Jeff Gibbs Receives FDLI Distinguished Service and Leadership Award; U.S. News Ranks HP&M as a Top FDA Law Firm; Attorneys Contribute to New Book on Health Care CommercializationDecember 13th, 2013

      It’s been quite a month for Hyman, Phelps & McNamara, P.C. (“HP&M”)!  First, the American Bar Association named the FDA Law Blog to the 2013 ABA Journal Blawg 100 (see here).  Now there are three more honors to report!  Earlier this week at the Food and …

    • Some Holiday Cheer! FDA Law Blog Chosen as One of the ABA Journal’s Blawg 100November 26th, 2013

      We at the FDA Law Blog (and Hyman, Phelps & McNamara, P.C.) have a lot to be thankful for this Thanksgiving and holiday season.  Thanks to our loyal readers, earlier this week, the American Bar Association (“ABA”) named our blog to the 2013 (and 7th …

    • Hyman, Phelps & McNamara, P.C. Names Two New DirectorsNovember 19th, 2013

      Hyman, Phelps & McNamara, P.C. is very pleased to announce that Larry K. Houck and Riëtte van Laack, PhD have been named Directors of the firm.  Mr. Houck’s practice area encompasses controlled substances and regulated chemicals as well as state licensing and registration compliance issues.  …