• where experts go to learn about FDA
  • Year: 2022

    • FDA Publishes Discussion Paper Seeking Feedback on 3D Printing of Medical Devices at the Point of CareJanuary 18th, 2022

      On December 10, 2021, FDA issued a discussion paper titled 3D Printing Medical Devices at the Point of Care seeking feedback on FDA regulatory oversight of various 3D-printing scenarios, in order to inform future policy development. This discussion paper is not the first time that FDA …

    • Is The Skinny Label Back From the Dead?January 12th, 2022

      Since the August 2021 decision in GSK v. Teva, the generic industry has been waiting with bated breath to see whether the section viii carve-out (and thus skinny-labeled generic drugs) will survive.  With the District Court of Delaware’s January 4 decision in a similar case …

    • We are hiring! HP&M Seeks Mid-Level FDA Regulatory AttorneyJanuary 10th, 2022

      Hyman, Phelps & McNamara, P.C. is the largest dedicated FDA law firm, and we need attorneys to help our clients bring pharmaceutical drugs and medical devices to market.  Our ideal candidates have experience working at FDA (CDER, CDRH, CBER, or OCC), or have at least …

    • District Court Interprets EKRAJanuary 7th, 2022

      “EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018.  EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s …

    • HP&M Promotes Sara Koblitz to DirectorJanuary 6th, 2022

      Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce that Sara W. Koblitz has become the firm’s newest Director.  Sara’s practice covers the intersection of FDA regulatory issues and Intellectual Property, including the Hatch-Waxman Amendments, the Biologics Price Competition and Innovation Act, and the …

    • Congratulations to HP&M’s first Principal Medical Device Regulation Expert, Adrienne LenzJanuary 6th, 2022

      Hyman, Phelps & McNamara, P.C. (HP&M) is pleased to announce Adrienne R. Lenz has become its first Principal Medical Device Regulation Expert.  Adrienne joined HPM in September 2017.  In her time with HPM, she has made significant contributions to the firm and its clients. Prior to joining …

    • Revised PhRMA Code Took Effect on January 1, 2022, and Certain State Obligations FollowJanuary 5th, 2022

      Happy New Year! On January 1, 2022, the recently revised version of the PhRMA Code on Interactions with Health Care Professionals went into effect. We summarized the major revisions to the Code in a blog post when it was released in August 2021. Many of the …

    • All Too Few (Two Year Version) or Where Have All the COVID Tests Gone?* A Review of FDA’s PoliciesJanuary 4th, 2022

      As we approach our third year of COVID, one of the major questions from March 2020 eerily echoes today: where are all the COVID tests?  The situation now, of course, is very different and much more favorable than two years ago.  Unlike March 2020, numerous …

    • Assessing the Credibility of Computational Modeling and Simulation in Medical Device SubmissionsJanuary 3rd, 2022

      On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance).  Computational modeling and simulation (CM&S) can sometimes be useful to demonstrate the safety and effectiveness of medical devices or incorporated into …