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The Top FCA Developments of 2020

Client Alert | less than 1 min read | 02.01.21

Like many other aspects of the legal landscape, 2020 was defined by COVID-19 and emerging areas of exposure and enforcement to come related to pandemic relief funding. But 2020 also saw many other important FCA developments, from case law developments on materiality, causation, pleading requirements, bars to qui tam actions, and the government’s authority to dismiss qui tams, among others. These highlights are among the important developments discussed by C&M attorneys in a “Feature Comment” published in The Government Contractor.

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....