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BIOSIMILARS AND STATE LEGISLATION

Posted by New Pharma Thinkers on January 15, 2014

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  Despite the fact that no biosimilars have actually reached the US market yet, debates about their use and substitution have been rumbling about since the first approach of patent expiries for biologic drugs. These debates, which have started to draw in state legislators, the FTC and even the World Health Organization (WHO), can all be traced back to how these

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BIOLOGICS AND BIOSIMILARS: REGULATORY PATHWAY IN THE UNITED STATES AND EUROPE

Posted by New Pharma Thinkers on December 09, 2013

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This webinar focuses on Regulatory Issues in the United States and Europe. This is the 1st in webinar series presented by Wilson Sonsini Goodrich & Rosati. Description: - Will discuss the FDA's recent publication of the proposed guidelines which is the first step the US has taken in defining what it is going to take for regulatory approval in the biosimilar space.

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OVERVIEW OF DRUG/DEVICE REGULATORY PROCEDURES IN THE UNITED STATES AND EUROPE

Posted by New Pharma Thinkers on December 09, 2013

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This webinar focuses on Regulatory Issues in the United States and Europe. This is the 2nd in webinar series presented by Wilson Sonsini Goodrich & Rosati. Description: Overview of the regulatory process - approval of small molecule, biologics and medical devices in the United States and Europe. This is an introduction, there are more feature seminars available of

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