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FDA Warns Three Foreign Drug Cos. of Consequences for Non-Payment of Fees
August 29, 2014 by Brian Feito|FDA

The Food and Drug Administration recently sent warning letters to three pharmaceutical companies that are delinquent on generic drug user fees. FDA says Cataire Chimie of France (here), Korea United Pharm of South Korea (here), and Explora Laboratories of Switzerland (here) have not yet paid 2013 or 2014 fees required by the Generic Drug User Fee Amendments of 2012. As a result, any drugs or active pharmaceutical ingredients from the companies may be misbranded, and FDA may place them on import alert if the fees aren’t paid. A full list of companies in arrears on generic drug user fees is (here).

FDA Issues New FAQ on UDIs for Medical Devices
August 29, 2014 by Brian Feito|FDA

The Food and Drug Administration issued a new FAQ document on its unique device identifier (UDI) system for medical devices. The guidance contains information on effective dates, label contents, and which products are subject to the new requirements. The UDI system will begin taking effect Sept. 24 for Class III devices.

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.