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Further Progress On What Used To Be The Berry Amendment

Client Alert | less than 1 min read | 07.05.07

For acquisitions of commercially available off-the-shelf (COTS) items, DOD has proposed to amend the DFARS to waive application of the statutory preference for domestic and qualified-country sourced specialty metals, formerly part of the Berry Amendment, but now codified at 10 U.S.C. 2533b (72 Fed. Reg. 35960 (July 2, 2007)) If adopted as a final rule, this waiver would be a major step toward making full compliance with the impractical statutory requirements a real possibility.

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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....