• How Vascular Solutions Beat the DOJ & What Medtech Executives Need to Know to Do the Same - Medtech Talk Podcast

    • Published on: June 14, 2016
    • Category: FDA News

    Mark DuVal was featured alongside Vascular Solutions CEO Howard Root in a Medtech Talk Podcast on May 26th, 2016.

  • FDA wants to know more about St. Paul's firms plans for Zika Virus Test

    • Published on: March 9, 2016
    • Category: FDA News

    Mark DuVal is quoted in a Star Tribune article.

    Amid growing international demand for rapid Zika testing, the Food and Drug Administration wants to know more about a Minnesota company's plans to sell a service to test for the virus in human lab samples.


  • Off-Label Discussion Before and During Clinical Trials

    • Published on: February 3, 2016
    • Category: FDA News

    Off-Label Communications: A Guide to Sales & Marketing Compliance
    3. Off-Label Discussion Before and During Clinical Trials

    By Mark E. DuVal  and Bradley Merrill Thompson

    I. Introduction

    By this point, the book has provided excellent background on the legal underpinnings for off-label promotion and dissemination. The task now is to discuss off-label uses of products in the context of clinical trials. This helps the reader understand how clinical trials intersect with off-label promotion and other forms of communication. Thus the chapter begins with a conceptual layout of how one might view this world. What does a manufacturer confront when it markets a product that has utility well beyond its approved label? Remember, to discuss “off-label” uses implies that the product is already approved, has a label and there is potential for off-label uses of that product. Also, remember that off-label does not mean that the off-label use is inappropriate, nor is it necessarily dangerous. Rather, it means the product is deemed safe enough to be on the market, but it has not been studied for that particular unapproved use.



  • CMS's redrawn exemption for CME disallows sponsor choice of speaker

    • Published on: November 3, 2014
    • Category: FDA News

    Mark Gardner was quoted in a Medical Device Daily article written by Mark McCarty, Washington Editor, regarding 2015-2016 changes to the Sunshine Act.

    The Centers for Medicare & Medicaid Services released the Medicare physician fee schedule for calendar 2015 in a classic government data dump on Halloween, and among the items included in the MPFS is a revised exemption for sponsor payments made for continuing medical education. The final rule explains that when an applicable party funds a CME, but "does not either select or pay the covered recipient directly," that payment would be excluded so long as the sponsor did not provide the CME provider with "a distinct, identifiable set of covered recipients to be considered as speakers" at the event (Inside the Beltway).

    Read the full article here.

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