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

(A Response to Mark E. Greenwold’s ‘What Standards Should FDA Apply in Ruling on Applications for Substantial Equivalence for Tobacco Products Under the Family Smoking Prevention and To...read more

by Mark Greenwold In this issue of the Policy Forum (Volume 2, Number 18, September 26, 2012) Mark Greenwold, Senior Consultant for the Campaign for Tobacco-Free Kids, discusses the Tobacco Control...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

Written by Sam F. Halabi, Assistant Professor of Law at the University of Tulsa, this Forum discusses what the author identifies as shortcomings in the current regulations governing modified risk t...read more

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