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Widespread WOSB and EDWOSB Contracting Problems

Client Alert | less than 1 min read | 06.26.18

A recent SBA OIG report found that the overwhelming majority – 50 out of 56 contracts reviewed – of Woman-Owned Small Businesses (WOSBs) sole source awards were awarded improperly. The SBA OIG found that the SBA generally failed to comply with a 2015 NDAA requirement moving WOSBs and Economically Disadvantaged Women-Owned Small Businesses (EDWOSBs) from a self-certification system to a third party-run certification system. The SBA OIG faulted the agency for failing to implement a government-run certification program and for permitting the improper award of contracts to firms that self-certify. The SBA OIG called on the agency to implement a government-run certification program for WOSBs and EDWOSBs, among other recommendations.

Insights

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....