Christopher M. Mikson, M.D.

Of Counsel
Washington,  DC  U.S.A.

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Experience & Credentials

Practice Areas

  • Intellectual Property
    University Rutgers University, B.A., 1984; University of Pennsylvania, Post Baccalaureate Premedical Program, 1999; Jefferson Medical College, M.D., 2005
    Law SchoolRutgers University, J.D., 1987
    Admitted1987, Pennsylvania and New Jersey; 2006, District of Columbia; registered to practice before the U.S. Patent and Trademark Office

     (Also at Washington, District of Columbia Office)


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    FDA Issues Draft Guidance on Determination of Reference Product Exclusivity for Biologics
    Colleen Heisey,Mark Mansour,Christopher M. Mikson, August 12, 2014
    On August 4, the U.S. Food & Drug Administration ("FDA") issued a draft guidance titled "Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act." The draft guidance is intended to assist biological product sponsors and applicants in...

    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

    Christopher M. Mikson, M.D.

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


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