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Legislation Aims to Improve Program Management

Client Alert | less than 1 min read | 12.19.16

On December 14, 2016, President Obama signed the Program Management Improvement Accountability Act. This law (1) creates a formal program manager job series and career path; (2) develops a government-wide, standards-based program management policy; (3) designates a senior executive to be responsible for agency policy and strategy; and (4) exchanges knowledge of successful approaches through an interagency council.

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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....