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CFC Sustains Corrective Action Protest Where Solicitation Amendment Favored Original Awardee

Client Alert | less than 1 min read | 11.28.16

In Prof’l. Serv. Indus. Inc. v. United States, the Court of Federal Claims sustained a protest of a corrective action that the Federal Highway Administration took in the wake of a GAO decision that the awardee’s proposed program manager lacked the requisite experience. The court found that the agency’s decision to amend the solicitation was arbitrary and capricious because the agency changed the required qualifications for the program manager—in a manner that conformed to the original awardee’s proposal—rather than conducting a re-evaluation of the proposals under the un-amended solicitation’s criteria.

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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....