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Cleared Contractors Under the Gun As Insider Threat Program Deadline Approaches

Client Alert | less than 1 min read | 11.17.16

By November 30, 2016, contractors that have facility clearances through DoD's Defense Security Service (DSS) must have a written plan in place for implementing an insider threat program, a new requirement under the National Industrial Security Program Operating Manual. As the deadline looms, our team’s recent BNA article provides practical pointers to help contractors turn the high-level DSS guidance into a detailed but practical plan.

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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....