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Setting the Floor: New FAR Rule Defines Minimum Contractor Information System Safeguarding

Client Alert | 1 min read | 05.17.16

Shifting approaches, on May 16, 2016, the FAR Council concluded a long-running rulemaking with a final rule and a new clause, FAR 52.204-21, that will establish minimum security controls pulled from NIST Special Publication 800-171 over contractor information systems that may process, store, or transmit “Federal contract information,” defined as information provided to or generated under any government contract (except for COTS) that is not intended for public release. Future rules will address more specific controls applicable to more sensitive information such as Controlled Unclassified Information (CUI), but this rule focuses instead on establishing those baseline controls the FAR Council believes any prudent business would implement in relation to its information systems and does not replace more stringent security requirements like those in the DFARS Safeguarding Rule.

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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....