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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FDA's Prior Notice Filing System to be Down Sept. 6, Says CBP

September 5, 2014 by Tim Warren|FDA

The Food and Drug Administration's stand-alone prior notice filing system will be down for maintenance from 1 a.m. to 10 a.m. on Saturday, Sept. 6, said CBP in a CSMS message. "During this downtime, ACS, OASIS and the link between ACS and OASIS will be operational," it said.

New and Revised FDA Import Alerts for Sept. 3

September 4, 2014 by Brian Feito|FDA

On Sept. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Posts Training Videos for Food Defense Plan Software

September 4, 2014 by Brian Feito|FDA

The Food and Drug Administration on Sept. 3 announced the availability new training videos to assist companies in using its “Food Defense Plan Builder” software designed to help companies protect themselves against intentional adulteration of food. The training videos help users answer a series of questions about the food facility and the associated food in order to develop a comprehensive food defense plan, including a vulnerability assessment, broad and focused mitigation strategies, and an action plan. The Food Defense Plan Builder software is available (here).

New and Revised FDA Import Alerts for Sept. 2

September 3, 2014 by Brian Feito|FDA

On Sept 2 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Other Modified FDA Import Alerts for the Week of Aug. 25 - 31

September 3, 2014 by Brian Feito|FDA

During the week of Aug. 25-31, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination and/or surveillance of:

New and Revised FDA Import Alerts for Aug. 29 - Sept. 1

September 2, 2014 by Brian Feito|FDA

On Aug. 29 - Sept 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Aug. 28

August 29, 2014 by Brian Feito|FDA

On Aug. 28 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Aug. 27

August 29, 2014 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 27 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

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.