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    • FDA Commissioner Scott Gottlieb Announces His ResignationMarch 7th, 2019

      On March 5, Scott Gottlieb, M.D., announced he will be stepping down as Commissioner of FDA.  His resignation will become effective in about one month.  His two-year tenure, since May 2017, has been very productive.  Gottlieb spearheaded initiatives on a variety of complex issues, including …

    • 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 …

    • 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 …

    • HP&M Snags Another Award: LMG Life SciencesNovember 16th, 2018

      As 2018 winds down, awards season is in full swing! Last week we announced that Hyman, Phelps & McNamara, P.C. (“HP&M”) was tapped by U.S. News and Best Lawyers as the recipient of the 2019 “Law Firm of the Year in FDA Law” award.  This …

    • Recruiting Class of 2018 – HP&M Adds Three New Attorneys and Two Regulatory ProfessionalsNovember 8th, 2018

      It’s been a busy year at Hyman, Phelps & McNamara P.C. as we’ve added three new attorneys and two regulatory professionals to our ranks.  The five professionals collectively add depth and breadth to our practice with FDA and industry experience. Deborah L. Livornese joined HP&M as …

    • HP&M Takes Home 2019 “Law Firm of the Year in FDA Law” Honors from U.S. News and Best LawyersNovember 8th, 2018

      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 …

    • The Obesity Epidemic: FDA’s Waistline Continues to Expand!November 5th, 2018

      Waaaaayyyy back in 2012, when life (and practicing food and drug law) was simpler, something caused us to study and evaluate the year-over-year change (i.e., the change in girth by the number of pages) in Title 21 of the Code of Federal Regulations (“CFR”) from …

    • Introducing FDA Law Blog 2.0!November 20th, 2017

      If you happened to log on to the FDA Law Blog or the Hyman, Phelps & McNamara, P.C. (“HPM”) websites over this past weekend, then you probably noticed some big changes. We’ve totally overhauled and upgraded the blog and the HPM websites to bring them …

    • FDA Finalizes Guidance on Mosquito-Related Products (Including Genetically Engineered Mosquitoes)October 24th, 2017

      FDA finalized a guidance that clarifies FDA and EPA jurisdiction over mosquito-related products, including mosquitoes produced through the use of biotechnology.  FDA had issued the draft guidance as part of a batch of biotech-related documents that were released in the final days of the Obama administration …

    • 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 …

    • Court Applies First Amendment Protections to FDA-Related ClaimsApril 25th, 2017

      Although the First Amendment has been more often discussed in the context of drug and medical device promotion, the Eleventh Circuit recently evaluated whether claims for a food also deserve similar constitutional scrutiny. In Ocheesee Creamery LLC v. Putnam, the Eleventh Circuit considered whether the …

    • A Decade of the FDA Law Blog!!March 5th, 2017

      Believe it or not, Hyman, Phelps & McNamara, P.C.’s FDA Law Blog turns 10 years old today (Monday, March 6, 2017). Where have all of the years gone?  It seems like Tuesday, March 6, 2007 was just yesterday.  That’s when we put up our initial …

    • Need Some Holiday Reading? Recent FDA Scholarship Worth a SpinDecember 29th, 2016

      Week 52 is often more laid back than any of the other 51 weeks in the calendar year. It offers us a chance to sift through and clean out the office in preparation for yet another busy year.  But it’s also a chance for this …

    • FDA Law Blog Named to ABA Journal’s Blawg 100 – Our 6th Time!December 2nd, 2016

      Earlier this week, we received notification 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 2016 (and 10th annual) ABA Blawg 100.  The Blawg 100 is a list of the …

    • CPSC Magnet Ban/Standard Vacated by 10th CircuitNovember 22nd, 2016

      By Riëtte van Laack – This case concerns small, high-powered magnet sets that users can arrange and rearrange in various geometric shapes. They were once a popular product, marketed as an adult desk toy and for making art works.  The magnet sets consist of 100-200 magnets …