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 July 31

August 1, 2012 by Brian Feito|FDA

On July 31 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA to Require Medical Device Importers to Participate in Electronic Registration

August 1, 2012 by Mike Feazel|FDA

The Food and Drug Administration is amending its regulations to comply with statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), it said in a Federal Register notice. It said the change would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act and update rules to improve the quality of registration and listing information available to FDA.

New and Revised FDA Import Alerts for July 30

July 31, 2012 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:

Other Modified FDA Import Alerts for the Week of July 23-29

July 31, 2012 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 of:

New and Revised FDA Import Alerts for July 27

July 30, 2012 by Brian Feito|FDA

On July 27 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 26

July 27, 2012 by Brian Feito|FDA

On July 26 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, 2012 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:

FDA Seeks Comments on Possible Changes to Animal Drug Sponsor Reports

July 26, 2012 by Brian Feito|FDA

The Food and Drug Administration is asking for comments on possible changes to its regulation requiring animal drug sponsors to submit reports, including periodic drug experience reports containing drug distribution data showing the amount of the drug distributed domestically and the amount exported. Specifically, FDA is seeking comments on: (1) whether it should require the submission of additional sales and distribution information including an estimate of the amount of each active antimicrobial ingredient sold or distributed for use in each approved food-producing animal species; (2) how to compile and present its annual summary report of the sales and distribution data collected from sponsors of antimicrobial new animal drugs; and (3) alternative methods available to FDA for obtaining additional data and information about the extent of antimicrobial drug use in food producing animals. Comments are due by Sept. 25.

New and Revised FDA Import Alerts for July 24

July 25, 2012 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 25

July 25, 2012 by Brian Feito|FDA

The Food and Drug Administration issued its weekly Enforcement Report for July 25 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.