Focus On Regulation

Italy towards the adoption of national templates for CTAs

Co-authored by Carlotta Busani, Trainee Solicitor, Milan

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We are the Champions – France and Germany unite to revive industrial policy at European level

Following the European Commission’s prohibition of the Alstom-Siemens transaction, the French and German governments published a manifesto calling for a reform of current EU merger...

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FDA’s Bendeka decision reverses approvals of Treanda generics

Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the...

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Medical Devices. Failed or delayed designation: what liability for notified bodies?

Organisations wishing to be designated as notified bodies must, on the basis of the new European Regulations, obtain a new designation in accordance with the requirements set out by the new ...

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Pharmacy compounding of patented medicines in the Netherlands

The pharmacy exemption came into force on 1 February 2019

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