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INSIGHTS & ANALYSES
FDA Risk-Evaluation Guidance Unlikely To Help Generics
Gregory Asciolla and Matthew Perez discuss the U.S. FDA’s guidances concerning risk evaluation and mitigation strategies and the likely minimal ...
Gregory Asciolla and Matthew Perez discuss the U.S. FDA’s guidances concerning risk evaluation and mitigation strategies and the likely minimal ...
We address the differences between the U.S. and EU regimes and how the EU is implementing a new litigation landscape. INTRODUCTION Access to the ...
This article explores the benefits and limitations of the proposed legislation, the CREATES Act of 2016. A bipartisan group of U.S. senators recently ...
As more biosimilar applications are filed, courts will inevitably face the novel and complex issues posed by the BPCIA with increasing frequency. I. ...
On June 11, 2013, the E.C. took another big step in its ongoing effort to make it easier for victims of antitrust violations in the European Union ...
There appears to be a modest trend favoring immunization of foreign conduct, but courts are still elusive as to providing a clear articulation of the ...