Laurie A. Clarke

Member
Washington,  DC  U.S.A.
Phone202-879-3939

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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
     
    ISLN901663281
     

    Documents by this lawyer on Martindale.com

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    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...

    Legislators and Groups Urge FDA to Require Sex-Specific Data, Labeling in New Action Plan
    Laurie A. Clarke,Colleen Heisey,Mark Mansour,Christopher M. Mikson,Emily K. Strunk, August 5, 2014
    Members of Congress and interest groups are pressuring FDA to promote sex-specific clinical research and product labeling, as the Agency develops an action plan to address deficiencies in the way industry collects, analyzes, and communicates demographic data.

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    Office Information

    Laurie A. Clarke

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




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