
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 to ...
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 ...
Attorney Advertising
Prior results do not guarantee a similar outcome. Some visual images used herein include models.
The materials appearing on this website are provided for informational purposes only and do not constitute legal advice. You should not take action based upon this information without consulting legal counsel. This site is not intended to create an attorney-client relationship. The hiring of a lawyer is an important decision that should not be based solely upon any single source of information, including advertising on this website. You may ask us to send you further information about us, and we urge you to review other sources of information about us.
Copyright © 2018 Labaton Sucharow LLP. All rights reserved.