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Proposed Federal Guidelines For Compliance Programs Published For Comment

Client Alert | less than 1 min read | 01.07.04

By our earlier Bullet Point (Oct. 7, 2003), we advised that the US Sentencing Commission was considering substantial revisions to its guidelines for organizations and courts on what constitutes an effective compliance program. The proposed guidelines were published on 12/30/03 (68 FR 75340) for public comment, closing on 03/01/04.

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....