|University ||Lycoming College, B.S., 1999; Johns Hopkins University School of Public Health, M.P.H., 2006|
|Law School||George Washington University, J.D., 2002|
|Admitted||2002, California; 2003, District of Columbia|
Documents by this lawyer on Martindale.com
FDA Finds that Artificial Trans Fats Are Unsafe
Edgar J. Asebey,Jonathan Berman,Colleen Heisey,Stephanie L. Resnik,Emily K. Strunk, June 24, 2015
On June 16, 2015, FDA announced it has finalized its determination that partially hydrogenated oils ("PHOs") are not "generally recognized as safe" ("GRAS") for use in human food. This finding effectively bans PHOs, which are the primary source of artificial trans fat...
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FDA recently finalized three draft guidance documents addressing scientific and regulatory issues associated with the development and licensure of biosimilars.
Amendment to Drugs and Medical Devices Law in Japan Takes Effect
Laurie A. Clarke,Colleen Heisey,Scott T. Jones,Mark Mansour,Mitsutaka Okano, December 16, 2014
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented. The amendment mainly covers (i) establishing a fast-track authorization process for regenerative medicine products (described below), (ii) restructuring medical device regulations, and (iii)...
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