Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ About?

Posted on February 2014 by Daniel A. Kracov, Partner, Abraham Gitterman, Associate, and Arnold & Porter, LLP

This issue of Policy Forum (Volume 4, Number 2, February 26, 2014) – Do We ‘Like’ FDA’s ‘First Social Media Guidance’ or is it Nothing to ‘Tweet’ Abo...read more

Do Pending State Biosimilar Substitution Bills Violate State Constitutional Law Principles of Non-Delegation and Incorporation by Reference?

Posted on September 2013 by Neal Parker Section Head, Legal, Biologics Strategic Development, AbbVie

In this Policy Forum, Parker explains that since Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2010, several state legislatures have introduced and some have enacte...read more

Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?

Posted on August 2013 by Ralph Hall, Professor of Practice at the University of Minnesota Law School, Of Counsel at Faegre Baker Daniels and CEO of MR 3 Medical LLC

This issue of Policy Forum (Volume 3, Issue 14, August 29, 2013)—“Is Caronia the Most Important FDA Related Judicial Decision of Our Generation?” by Ralph Hall (Professor of Pract...read more

by Jonathan Stroud Is Congress Politicizing Patents? Patenting Biotechnology in the Wake of Section 33 and Prometheus is the timely topic by Author Jonathan Stroud, former Patent Examiner at t...read more

James M. Solyst of ENVIRON International Corporation makes the argument that, at a time when federal budgets are precarious, the private sector must be prepared to continue to contribute to the sci...read more

by Jamie Kendall and Noah Mallon The authors assert that FDA’s vagueness in the December 27, 2011-released Draft Guidance for Responding to Unsolicited Requests for Off-Label Information (&l...read more

Must FDA Engage in Rulemaking to Regulate Laboratory-Developed Tests?

Posted on September 2011 by Gail H. Javitt, Katherine Strong Carner

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