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Section 3610 Billing Guidance

Client Alert | less than 1 min read | 04.13.20

Crowell & Moring has collected and analyzed the available, agency-specific billing guidelines for government contractors submitting CARES Act Section 3610 invoices. The information is collected here. A PDF version can be found here.

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....