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OGE Issues Final Rule on Gifts

Client Alert | 1 min read | 11.22.16

The Office of Government Ethics has issued a final rule revising the Standards of Ethical Conduct for Employees of the Executive Branch applicable to the solicitation and acceptance of gifts from outside sources imposing a duty to decline otherwise permissible gifts when the appearance of impropriety is present, adding new examples of how to apply the rules, codifying previous interpretations of the gift rule, and retaining the $20 de minimis exception. In the rule, discussed more fully here, OGE says it will provide additional guidance and training as warranted.

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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....