Proposed DFARS Rule to Provide Guidance on Assessing Commercial Price Reasonableness
Client Alert | less than 1 min read | 08.05.15
On August 3, the DoD issued a proposed rule, with comments due by October 2, to amend the DFARS to clarify the amount and types of data that contracting officers may require from contractors in order to perform price reasonableness assessments for commercial items. The proposed rule addresses (1) the conditions under which prior sales information is sufficient, (2) when "uncertified cost data" will be required and the required format, and (3) the limits on requiring additional cost information when there are "sufficient nongovernment sales to establish reasonableness of price."
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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
