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Déjà Vu: Congress Orders DCAA to Revise Guidance on Access to Internal Audit Reports

Client Alert | less than 1 min read | 01.15.13

Section 832 of the FY 2013 NDAA requires DCAA to issue new guidance on access to contractors' internal audit reports to "ensure" that requests for access to them "are appropriately documented," following guidance issued by the agency in August 2012. The revised guidance will require DCAA to keep tabs on such requests and responses to them, but sets limits on what internal audit reports can be used for and stops short of language in the Senate version of the bill, under which the contractor's refusal to provide access would have been "a basis for disapproving the contractor business system or systems."


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....