|University ||Rutgers University, B.A., 1984; University of Pennsylvania, Post Baccalaureate Premedical Program, 1999; Jefferson Medical College, M.D., 2005|
|Law School||Rutgers University, J.D., 1987|
|Admitted||1987, 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)
Documents by this lawyer on Martindale.com
FDA Finalizes Three Guidance Documents on Biosimilars
Edgar J. Asebey,Maureen Bennett,Christian B. Fulda,Colleen Heisey,Christopher M. Mikson, May 15, 2015
FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.
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...
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