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DoD Mandates Preparation for Climate Change

Client Alert | less than 1 min read | 01.18.16

On January 14, 2016, DoD issued Directive 4715.21 (Climate Change Adaptation and Resilience), which establishes a comprehensive framework for agency efforts to (i) address, mitigate, and adapt to climate change risks to U.S. military assets and operations; and (ii) integrate climate change risk considerations into DoD acquisition and mission planning. As described in this post [MAKE THIS A LINK], the DoD Directive does not address several questions that will likely be answered on a piecemeal basis through multiple new or modified regulations, standards, and guidelines, providing the private sector with several opportunities to shape implementation of the directive and to address downstream effects to contracts and corporate policies.

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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....