Blogs

Focus On Regulation

Will FDA be forced to implement a drug importation program?

Over a year ago, HHS Secretary Alex Azar requested that FDA establish a working group to explore how drug importation “could help address price hikes and supply disruptions.”...

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Green light for therapeutic cannabis experiment in France

The French legislator has always placed strict restrictions on the use of therapeutic cannabis. But the situation and legislation are evolving in France.

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The Court of Justice clarifies the EU customs rules applicable to customs valuation

The Court of Justice of the European Union ("Court") just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines...

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Foreign Investment Control on the Rise – New List of EU Member States' FDI Screening Mechanisms

Foreign direct investment ("FDI") screenings have become a relevant factor for global transactions in recent years. More and more jurisdictions are introducing or ramping up their powers...

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FDA launches temporary “TRIP” program to help HCT/P sponsors gain regulatory clarity

Acting Food and Drug Administration (FDA) Commissioner Ned Sharpless, M.D. recently announced that FDA is implementing a temporary program called the Tissue Reference Group Rapid...

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