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Pre-Award Protest Timeliness Rule Extended

Client Alert | less than 1 min read | 12.18.12

In Comint Sys. Corp. v. U.S. (Dec. 7, 2012), the Federal Circuit extended its judicially imposed timeliness rules to require a protest of a solicitation defect to be filed in court prior to award, if practical, even if the alleged error occurred after proposals had been submitted. The court noted that this is consistent with the GAO timeliness rules.


Insights

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....