Coleen Klasmeier

Sidley Austin LLP

Partner

1501 K Street, N.W.

Washington, DC 20005

United States

http://www.sidley.com/klasmeier_coleen/

SCHOLARLY PAPERS

3

DOWNLOADS

778

SSRN CITATIONS

0

CROSSREF CITATIONS

0

Scholarly Papers (3)

1.

NDA Approval Under FDCA Section 505(b)(1) Based on Effectiveness Data from One Clinical Trial

Number of pages: 45 Posted: 25 Jan 2012 Last Revised: 30 Jul 2013
Coleen Klasmeier and Torrey Cope
Sidley Austin LLP and Sidley Austin LLP
Downloads 330 (111,716)
Citation 1

Abstract:

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2.

Off-Label Prescription Advertising, the FDA and the First Amendment: A Study in the Values of Commercial Speech Protection

American Journal of Law and Medicine, Volume 37, Numbers 2&3, 2011
Number of pages: 38 Posted: 28 Mar 2011 Last Revised: 28 Jul 2013
Coleen Klasmeier and Martin H. Redish
Downloads 257 (145,287)

Abstract:

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Food and Drug, Constitutional Law, Free Expression, Commercial Speech, Administrative Law, First Amendment

3.

FDA Regulation of Off-Label Promotion: An Answer

Number of pages: 21 Posted: 09 Feb 2012
Coleen Klasmeier
Sidley Austin LLP
Downloads 191 (192,500)
Citation 1

Abstract:

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off-label promotion, substantial evidence, FDA regulation, food & drug