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    • The Final Safety and Performance Based Pathway Guidance Is OutFebruary 21st, 2019

      You might remember our prior post on FDA’s proposed expansion of the Abbreviated 510(k) Program. FDA recently issued a final guidance on this program with a brand-new name: Safety and Performance Based Pathway. Other than the new moniker, the final guidance does little to change …

    • Balancing Benefit and Risk in Medical Device RegulationFebruary 20th, 2019

      Medical devices provide important diagnostic and treatment benefits to patients. Every day, thousands of patients are the beneficiaries of amazing technology that often did not exist even 10 years ago, and certainly not 50 years ago. At the same time, these medical devices can pose risks …

    • CBER’s Learnings on Regenerative Medicine Development Reflected in Guidance UpdatesFebruary 19th, 2019

      With a little over a year under FDA’s belt implementing its Comprehensive Regenerative Medicine Policy Framework (which we blogged about here), CBER has updated its current thinking with the issuance of final versions of the two Regenerative Medicine Advanced Therapy (“RMAT”)-related guidance documents: Expedited Programs for …

    • You Down With CGT?February 18th, 2019

      Yeah, you know me. Given Commissioner Gottlieb’s clear proclivity for blog posts with song titles rather than Orange Book puns, we’ll stick with those for a while. We just hope the Commissioner likes early 1990s rap as much as he likes rock from the 1970s …

    • FDA Announces Various Initiatives to Increase Oversight of the Dietary Supplement IndustryFebruary 15th, 2019

      On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018.   In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts …

    • FDA Issues Final Guidance on Least Burdensome ProvisionsFebruary 13th, 2019

      On February 5, 2019, FDA issued the guidance document The Least Burdensome Provisions: Concept and Principles (Final Guidance).  This version supersedes the prior version in place since October 2002.  FDA published a draft of the guidance (Draft Guidance) in December 2017, which we blogged on …

    • FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same MessageFebruary 12th, 2019

      FDA released its annual Report to Congress on 505(q) Citizen Petitions last week – the Tenth Annual Report to Congress on Delays in Approvals of Applications Related to Citizen Petitions and Petitions for Stay of Agency Action for Fiscal Year 2017.  The Report, which is …

    • 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 …