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Navy's Sparse Document Production Sinks Protest Defense

Client Alert | less than 1 min read | 12.28.15

In CORTEK, Inc. (Dec. 17, 2015), GAO determined that it could not find the Navy's evaluation and award decision reasonable when, in response to the protest, the Navy produced only very circumscribed portions of selected documents that were extensively redacted, to the point that the agency report failed to explain even the most basic details of the acquisition. The Navy's overly aggressive efforts to limit document production frustrated CICA's mandate that GAO resolve bid protests and led GAO to sustain the protest regarding the evaluation of several aspects of the awardee's proposal.

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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....