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Agency's Stafford Act Interpretation Rejected

Client Alert | less than 1 min read | 11.12.07

In Executive Protective Security Service, Inc. (Oct. 22, 2007, http://www.gao.gov/decisions/bidpro/2999543.pdf), GAO sustained the protest on the basis that FEMA had improperly interpreted the “doing business primarily” eligibility requirement of the Robert T. Stafford Disaster Relief and Emergency Assistance Act. GAO determined that the act’s plain language and legislative history required that a firm must conduct a majority of its business in the designated disaster area to be considered for a Stafford Act award.

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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....