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Final Rule Requires Technical Interchange for IR&D Cost Allowability

Client Alert | 1 min read | 11.14.16

On November 4, 2016, DoD issued a final rule requiring contractors performing IR&D projects initiated in FY2017 or later to engage in a technical interchange with DoD, and report the occurrence of this interchange, before the costs for such projects may be deemed allowable (a topic previously discussed here). Although the rule is stated to be intended to promote DoD awareness of IR&D projects and provide feedback to contractors, it is likely to impose an administrative burden on contractors and DoD alike and could have a chilling effect on IR&D investment, particularly because it is silent regarding the allowability of IR&D costs if DoD fails to engage.

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....