FAPIIS Information To Be Publicly Available
Client Alert | less than 1 min read | 08.03.10
On July 29, 2010, President Obama signed the supplemental appropriations bill which contained a provision amending the Clean Contracting Act of 2008 -- the legislation that gave rise to the Federal Awardee Performance and Integrity Information System ("FAPIIS"). As a result of the new language ("the Administrator shall post all such information, excluding past performance reviews, on a publicly available Internet website"), information in FAPIIS must be made available to the public, except for past performance reviews.
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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.
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