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Only One Place to Go for In-sourcing Challenge

Client Alert | less than 1 min read | 04.14.14

In Fisher-Cal Indus., Inc. v. U.S. (Apr. 8, 2014), the D.C. Circuit bounced an incumbent's challenge to the agency's in-sourcing decision. Finding the decision to be part of the procurement process, the court ruled that it was, in essence, a bid protest that could be brought only in the Court of Federal Claims.


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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....