Agencies Abuse Sole-Source Process
Client Alert | less than 1 min read | 02.20.13
On the heels of the CFC in Innovation Dev. Enters. of Am., Inc. v. U.S. (Jan. 29, 2013) finding that the Air Force had done zero advance planning before improperly justifying retention of the multiyear incumbent on a sole-source basis, the GAO issued its study faulting DOD more generally. In reviewing eight large sole-source awards, GAO found that DOD in six of them had failed to adhere to the recently tightened FAR requirements for sole-source buys.
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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.
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FTC Issues Five-Year Strategic Plan: What Businesses Need to Know
