Expanding FAPIIS: First "Ownership," Now "Predecessors"
Client Alert | less than 1 min read | 12.17.14
On December 4, 2014, the FAR Councils issued a proposed rule that would require offerors to disclose all "predecessor" entities that held a federal contract or grant within the prior three years, with comments due by February 2, 2015. This information, in addition to the recent addition of ownership information, will be stored in the Federal Awardee Performance and Integrity Information System (FAPIIS).
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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.
Client Alert | 4 min read | 04.13.26
Client Alert | 4 min read | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
