DoD White Paper Takes Aim at IR&D Costs
Client Alert | 1 min read | 09.01.15
While DOD's August 26 white paper "Enhancing the Effectiveness of Independent Research and Development" explains that the intent of new requirements it announced is "not to reduce the independence of IR&D investment selection, nor to establish a bureaucratic requirement for government approval prior to initiating an IR&D project," contactors have good reason to doubt that assertion. Most significantly for contractors, there will be a new DFARS rule under which, "beginning in FY 2017, DoD will require contractors to record the name of the government party with whom, and date when, a technical interchange took place prior to IR&D project initiation and to provide this information as part of the required IR&D submissions made to [DTIC]," and DCMA and DCAA "will use these DTIC inputs when making allowability determinations for IR&D costs."
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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 | 04.10.26
CMS Finalizes Rate Notice for Medicare Parts C and D (CY 2027)
Client Alert | 2 min read | 04.10.26
Client Alert | 4 min read | 04.10.26
FTC Issues Five-Year Strategic Plan: What Businesses Need to Know

