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DoD's Proposed Counterfeit Electronic Parts Rules Are Short on Details

Client Alert | 1 min read | 05.22.13

Following up on its publication of an instruction on counterfeit parts on May 16, DoD issued a long-expected proposed rule on counterfeit electronic parts avoidance, detection, and liability, with comments due by July 15. As discussed on our blog, the rule -- which applies only to CAS-covered prime contractors but will have a much broader impact on subcontractors and suppliers -- requires that business systems include DoD-approved avoidance and detection systems, but leaves the details of the newly required systems to be fleshed out, it would seem, by DCAA and/or DCMA, and, while it imposes potentially unlimited liability for counterfeit parts, it has an exceedingly narrow "safe harbor." 


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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....