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EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding. 

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NAFTA Tribunal Rules Against Challenge to FDA Import Alert, Says Canadian Pharma Co.
August 28, 2014 by Brian Feito|FDA

A NAFTA arbitration tribunal has rejected claims by a Canadian pharmaceutical exporter that the Food and Drug Administration violated the agreement by restricting imports from two of its facilities, according to a press release from the Canadian company. Apotex says an FDA import alert that prohibited imports from two Apotex facilities in Etobicoke and Signet, Canada “effectively removed Apotex from the U.S. solid-dose drug market for almost two years.” But the NAFTA tribunal found in a still-confidential ruling that the import alerts did not violate NAFTA rules, it said. The ruling will be released after a review to remove confidential information (here), said Apotex.

FDA Loosens Controls on Hemoglobin Test System
August 25, 2014 by Brian Feito|FDA

The Food and Drug Administration is classifying hemoglobin A1c test systems as Class II devices that do not require premarket approval, in an order that codifies a classification that took effect May 23, 2013. The devices had been classified in Class III, and required the filing of a premarket approval application before distribution. Although they will no longer need FDA approval, the devices will still be subject to certain extra "special controls" related to testing and labeling. They will not be exempt from premarket notification requirements.