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SBA Size Standards Revised To Cap Number Of Employees

Client Alert | less than 1 min read | 04.18.04

The SBA has proposed major revisions to its size standard for determining eligibility for qualification as a small business concern, with comments due by May 18, 2004. Among other changes, the newly proposed size standard are generally stated in terms of the maximum numbers of employees of the concern, but for some industries there is a cap on the average annual receipts as well.

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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....