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 Raises Fees for Import & Facility Reinspections, Etc. for FY 2014; Still No Invoices

August 1, 2013 by Brian Feito|FDA

The Food and Drug Administration raised potential fiscal year 2014 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees. The FY 2014 fees of $237/hour for domestic services and $302/hour if foreign travel is required are higher than the FY 2013 fees of $221/hour and $289/hour, respectively. The fees are effective Oct. 1.

New and Revised FDA Import Alerts for July 30

July 31, 2013 by Brian Feito|FDA

On July 30 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 July 29

July 30, 2013 by Brian Feito|FDA

On July 29 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 July 23-29

July 30, 2013 by Brian Feito|FDA

During the week of July 23-29, 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 Posts Guidance on Safety-Related Labeling Changes for Drugs

July 30, 2013 by Brian Feito|FDA

A guidance is available on Food and Drug Administration-required safety labeling changes for some prescription drug and biological products (here). Under the 2007 Food and Drug Administration Amendments Act, FDA can require certain drug and biological product application holders to make safety-related labeling changes based on newly-available safety information that becomes available after product approval. The authority does not apply for non-prescription drugs, said FDA.

New and Revised FDA Import Alerts for July 26-28

July 29, 2013 by Brian Feito|FDA

On July 26-28 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 July 25

July 26, 2013 by Brian Feito|FDA

On July 25 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 July 24

July 25, 2013 by Brian Feito|FDA

On July 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 July 24

July 25, 2013 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 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 July 23

July 24, 2013 by Brian Feito|FDA

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