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DCAA Issues (Mis)Guidance on Expressly Unallowable Costs

Client Alert | less than 1 min read | 02.23.15

On January 7, 2015, DCAA issued guidance to auditors for determining whether certain costs are "expressly unallowable" – and therefore subject to penalties – even when the regulations "do not state in direct terms that the cost is unallowable." This guidance, which is intended to "enhance" the equally troubling December 18 guidance to similar effect, is inconsistent with the CAS 405 definition of "expressly unallowable cost" (i.e., "a particular item or type of cost which, under the express provisions of an applicable law, regulation, or contract, is specifically named and stated to be unallowable") and will likely lead to confusion in the audit process and undoubtedly result in DCAA auditors assessing more penalties against contractors on dubious grounds.

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....