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Annual ISDC Reporting

Client Alert | less than 1 min read | 11.07.19

The annual Interagency Suspension and Debarment Committee recently issued its annual report to Congress. The report, found here, contains details of the state of the federal suspension and debarment program for Fiscal Year 2018 (note the significant timelag). The report notes a focus on cybersecurity contractor compliance issues, and proposals to modernize/streamline lead agency coordination. Otherwise, total numbers of suspensions, proposed debarments, and debarments continued to decline year-over-year, while pre-notice interactions with contractors continued to comprise a significant portion of SDO offices’ dockets.

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....