Laurie A. Clarke

Washington,  DC  U.S.A.

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Experience & Credentials

Practice Areas

  • Health Care
    University Smith College, A.B., 1985; Harvard University, M.P.P. 1987
    Law SchoolStanford University, J.D. 1990
    Admitted1991, Massachusetts and District of Columbia

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    FDA Releases Framework for Overseeing Laboratory Developed Tests
    Laurie A. Clarke,Brigid C. DeCoursey,Colleen Heisey, October 16, 2014
    On September 30, 2014, the U.S. Food and Drug Administration ("FDA") released the two draft guidance documents setting forth FDA's proposed framework for regulating Laboratory Developed Tests ("LDTs") as medical devices: (i) Draft Guidance for Industry, Food and Drug...

    FDA Accepts First Application for Biosimilar Product
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, August 5, 2014
    In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act...

    FDA Using Big Data Methods to Discover Drug Risks, Provide Access to Recall Information
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, August 5, 2014
    Through recently deployed initiatives, FDA is taking advantage of new data systems to gather and assess drug risk data and promote easier public access to adverse event and recall information. The two projects, Mini-Sentinel and open FDA, offer greater efficiencies than existing methods, such as...

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    Office Information

    Laurie A. Clarke

    51 Louisiana Avenue, N.W.
    WashingtonDC 20001-2113


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