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    • And the Nominees Are…. FDA Law Blog’s Top 10 Device Posts of 2018February 11th, 2019

      The recent government shutdown gave us some time to reflect on 2018, a year that was full of device-related posts.  Inspired by the recent Academy Awards nominations, we are now listing our Top Ten Device Posts of 2018.  Some are blockbusters, and others indie stories, …

    • 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 …

    • New Efforts to Expand Access to Laboratory Tests in MarylandFebruary 6th, 2019

      Readers who work with laboratory tests are likely aware that such tests can be subject to regulation by FDA, CMS, and individual states. A few state laws, particularly those in Maryland, New York, New Jersey, and Rhode Island, currently constrain how some laboratory tests are …

    • Congress Floats Discussion Draft of IVD LegislationFebruary 5th, 2019

      Since FDA announced in late 2016 that it would not finalize its laboratory developed test (LDT) guidances, it has become clear that any change to the LDT regulatory framework (at least during this administration) would need to come through a statutory change.  The first such …

    • Orange You Glad We Didn’t Make an Orange Book Pun?February 4th, 2019

      In yet another step to address drug pricing, Commissioner Gottlieb announced last week several new initiatives, including an update to the revered Orange Book.  Cue the crazy Muppet arms!  Proclaiming the Orange Book update a “transparency initiative,” FDA expects that this undertaking will “provide greater …

    • This Cannot Stand, Man! The BLOCKING Act of 2019 Would Unnecessarily Reform 180-Day Generic Drug ExclusivityFebruary 1st, 2019

      Over the 12 years that we’ve been doing this blogging gig, we’ve never before drawn inspiration for a post from Lebowski Pony – a.k.a. “the Dude” – that iconic character from the 1998 film The Big Lebowski, written and directed by Joel and Ethan Coen. …

    • OIG Proposed Safe Harbor Revisions Take Aim at Formulary Rebates, Volume-Based PBM Administrative FeesFebruary 1st, 2019

      Yesterday the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (“OIG”) released a proposed rule to put into practice an idea floated in HHS’ May 2018 Blueprint for lowering drug prices:  eliminating discount safe harbor protection for manufacturer rebates offered …

    • Key Insights from FDA’s Webinar on the Breakthrough Designation ProgramJanuary 31st, 2019

      FDA recently hosted a webinar on the final guidance regarding the Breakthrough Devices Program.  The Breakthrough Device Program is meant to speed access to new devices that treat or diagnose “life-threatening or irreversibly debilitating diseases or conditions.”  See our previous post for a more in-depth …

    • HP&M’s Anne Walsh to Present on Pharmacovigilance & Drug Safety IssuesJanuary 31st, 2019

      Hyman, Phelps & McNamara, P.C. is pleased to announce that Anne Walsh will present at this year’s Pharmacovigilance & Drug Safety: Risk Management & Regulatory Compliance Conference, to be held in Arlington, VA on March 12-13, 2019.   The focus of her presentation is on post-market …

    • Commissioner Gottlieb and CBER Director Marks Deliver “State of Cell and Gene Therapy” Joint StatementJanuary 30th, 2019

      As we await our nation’s State of the Union address, FDA’s own Commissioner Scott Gottlieb and Center for Biologics Evaluation and Research (CBER) Director Peter Marks issued a joint statement providing a state of union of sorts on the development and regulation of cell and …

    • Petition to Bar Hydroponic Operations from Organic CertificationJanuary 29th, 2019

      The question of whether hydroponic operations are eligible for organic certification in the United States has been debated since 1995.  In most countries, such as Mexico and Canada, and regions, such as the EU, organic certification cannot be extended to crops not grown in soil.  …

    • FDLI to Sponsor Webinar on Patient Assistance ProgramsJanuary 28th, 2019

      Next Thursday, February 7, the Food and Drug Law Institute will conduct a webinar entitled, “Patient Assistance Programs, Recent Enforcement and Best Practices.”  The webinar will cover the various forms of patient assistance programs, the legal authorities that apply to them, recent enforcement actions, best …

    • Case Dismissed: Strike Two for PMRSJanuary 28th, 2019

      In one of the multiple lawsuits that Pharmaceutical Manufacturing Research Services (PMRS) has filed against the FDA related to the approval of abuse-deterrent opioids in the last few years, the Eastern District of Pennsylvania summarily rejected PMRS’s bid to keep abuse-deterrent opioid, RoxyBond, off the …

    • Updates to FDA’s Software Pre-Certification ProgramJanuary 25th, 2019

      On January 7, 2019, FDA released new documents related to its Software Pre-Certification (Pre-Cert) Program: Developing a Software Precertification Program: A Working Model (Working Model) Software Precertification Program: Regulatory Framework for Conducting the Pilot Program within Current Authorities (Regulatory Framework) Software Precertification Program: 2019 Test Plan (Test Plan) In …

    • FDA Issues Final Rule on Medical Device Classification ProceduresJanuary 24th, 2019

      On December 17, 2018, FDA published a final rule, Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures, to amend its regulations governing classification and reclassification of medical devices to align with the relevant portions of the Federal Food, Drug, …