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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New and Revised FDA Import Alerts for Oct. 24

October 25, 2012 by Brian Feito|FDA

On Oct. 24 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 Oct. 24

October 25, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for Oct. 24 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Oct. 23

October 24, 2012 by Brian Feito|FDA

On Oct. 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Announces Generic Drug User Fees for FY 2013

October 24, 2012 by Brian Feito|FDA

The Food and Drug Administration announced its fiscal year 2013 abbreviated new drug application (ANDA), prior approval supplement (PAS), drug master file (DMF), and backlog fees, pursuant to the Generic Drug User Fee Amendments (GDUFA) of 2012. The fees are effective Oct. 1, 2012, and will run until Sept. 30, 2013. Going forward, FDA will publish GDUFA fees 60 days prior to the beginning of each fiscal year, it said. GDUFA fees are expected to generate $299 million annually for FDA. The fees will be used to conduct activities such as increased inspections of foreign facilities.

FDA Threatens Device Importer with Seizure, Civil Penalties for CGMP & MDR Violations

October 24, 2012 by Brian Feito|FDA

The Food and Drug Administration sent a warning letter to medical device importer Primus Medical on Oct. 10, alleging an inadequate response to an inspection that revealed deviations from Current Good Manufacturing Practices (CGMP) regulations and failure or refusal to furnish information required by Medical Device Reporting regulations.

New and Revised FDA Import Alerts for Oct. 22

October 23, 2012 by Brian Feito|FDA

On Oct. 22 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 Oct. 15-21

October 23, 2012 by Brian Feito|FDA

During the week of Oct. 15-21, 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:

FDA Finalizes Guidance on Food Product Categories on Facility Registrations

October 23, 2012 by Brian Feito|FDA

The Food and Drug Administration formally announced the availability of its final guidance on the “Necessity of the Use of Food Product Categories in Food Facility Registrations and Updates to Food Product Categories” in a notice set for publication in the Oct. 24 Federal Register. The guidance was issued Oct. 19, in conjunction with the beginning of food facility registration renewal. The guidance includes FDA’s determination that information about food product categories in food facility registrations is necessary for a quick, accurate, and focused response to a food safety related issue or incident, an actual or potential bioterrorist incident, or other food-related emergency, and identifies the additional food product categories included as mandatory fields in food facility registrations, as follows:

New and Revised FDA Import Alerts for Oct. 19-21

October 22, 2012 by Brian Feito|FDA

On Oct. 19-21 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 Oct. 18

October 19, 2012 by Brian Feito|FDA

On Oct. 18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: