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Agencies May Not Rely On Flawed DCAA Audits

Client Alert | less than 1 min read | 02.04.10

In McKissak+Delcan JV II (Jan. 13, 2010), GAO for what may be the first time rejected a DCAA determination that the offeror’s accounting system was inadequate and sustained the protest because the agency had improperly relied on DCAA’s determination in rejecting the offeror’s proposal. Adequacy of business systems is an element of an agency’s responsibility determination when evaluating proposals, and bid protests are likely the only viable forum for contractors to contest findings of system inadequacies.

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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....