Wherefore Software In Analyzing Substantial Transformation
Client Alert | 1 min read | 08.10.10
On August 6, 2010, Customs & Border Protection (CBP) published a final determination (75 Fed. Reg. 47609) that Avaya’s Unified Communication Solution was substantially transformed in the United States based upon the totality of the circumstances including installation of the Communication Manager software and the extensive effort at the installation site to integrate the largely foreign hardware components into a working system. CBP rejected Avaya’s assertion that the installation location of software that provides the functionality of a system or hardware could be the sole determinant of substantial transformation under CBP’s prior precedent, as the origin of the software has also been an important factor, and noted here that most of the software development had occurred at Avaya’s Colorado facility, although some ongoing software development now occurs abroad.
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Client Alert | 4 min read | 04.08.26
Cosmetics Under the Microscope: FDA’s Expanding Regulatory Reach Under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marked the most significant expansion of FDA’s authority over cosmetics in 80 years — and the agency is putting that authority to work. From the launch of a new adverse event reporting tool to forthcoming rules on fragrance allergens and good manufacturing practices (GMP), FDA is reshaping the regulatory landscape for manufacturers, packers, and distributors of cosmetic and personal care products.
Client Alert | 11 min read | 04.08.26
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Answering the Top Seven Questions About Pending Section 301 Deadlines
