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GSA Transactional Rule Pilot Program – Understanding the Seismic Shift

Client Alert | less than 1 min read | 08.29.16

The GSA’s Transactional Data Rule Pilot Program has been rolled out for certain schedules, but many questions remain for contractors, including the logistical challenges related to the monthly compilation of data, the ability of GSA contracting officers to compare products and services accurately as the agency moves from commercial pricing to horizontal pricing analysis, and the areas of potential liability under this new program. This article by C&M attorneys, published in Bloomberg BNA, provides a detailed explanation of the new rule and practical considerations for government contractors.

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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....