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GAO Repeats Protective Order Warning

Client Alert | less than 1 min read | 04.03.08

In denying the motion for reconsideration of its dismissal of the protest in PWC Logistics Servs. (Mar. 31, 2008) for breach of the protective order by the client retaining for a week protected material and distributing it within the company, GAO repeated that this case is to serve as a warning to other protestors: if the client receives from its attorneys any materials that are marked as subject to protective order, they are immediately to close and return or destroy the materials, and their attorneys are to provide prompt notice of the violation.

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Client Alert | 5 min read | 04.13.26

EU Pharma Package: Global (Orphan) Marketing Authorization Compromise Proposal

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA). We discussed in particular the missed opportunities in the Pharma Package to further codify and clarify the GMA, in view of its central role in determining the regulatory data protection (RDP) rights of a medicinal product....