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OMB Proposes a 21st Century Federal Grants Regulatory Structure

Client Alert | less than 1 min read | 02.04.13

On February 1, 2013, OMB published a proposal to consolidate eight existing OMB circulars, establishing uniform standards for administrative requirements, cost principles, and audit requirements for all grants and cooperative agreements. While OMB's primary focus appears to be on consolidating existing federal financial participation regulations, OMB also included a "cross-walk" to the current Circular A-110 identifying the proposed policy changes and updates if the proposal were adopted.


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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....