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Turn Square Corners or Sit on Sideline

Client Alert | less than 1 min read | 01.09.12

The Federal Circuit in Digitalis Educ. Solutions, Inc. v. U.S. (Jan. 4, 2012) emphasized that a company wanting to protest must itself satisfy the stipulated process. In this case, the company lost its right to complain of a sole-source award to a competitor because it did not routinely check FedBizOpps, where the agency published a notice of the proposed award, or submit its own statement of capability to show it could do the job, as the notice in FedBizOpps required.

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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....