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Contractors Can Review and Object to Public Release of Information in FAPIIS

Client Alert | 1 min read | 01.03.12

On January 3, 2012, the FAR Council issued a final rule to implement a congressional mandate that the public have access to all information (excluding past performance reviews) in the Federal Awardee Performance and Integrity Information System ("FAPIIS"), which was created in 2010 as a one-stop shop for contracting officers to review information about contractors' business ethics, integrity, and performance.  In response to concerns raised about the disclosure of a contractor's proprietary and confidential information, the final rule added a requirement that contractors be given a seven-calendar-day review period to object to the public release of information on the grounds that such information is exempt from disclosure under FOIA.

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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....