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Contending with Federal Investigations

Client Alert | less than 1 min read | 10.22.15

Crowell & Moring attorneys lend their voices to WFED radio today. Listen in at 12:30 pm EDT as these practitioners discuss the triggers of a federal investigation, how to formulate an investigative plan (including review of recent key developments), and corrective action measures.

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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....