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 Feb. 12

February 13, 2015 |FDA

On Feb. 12 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 Feb. 11

February 13, 2015 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Feb. 11 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Feb. 11

February 12, 2015 |FDA

On Feb. 11 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 Dec. Feb. 2-8

February 10, 2015 |FDA

During the week of Feb. 2-8, 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 Feb. 9

February 10, 2015 |FDA

On Feb. 9 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 Feb. 6

February 9, 2015 |FDA

On Feb. 6 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 Feb. 4

February 6, 2015 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Feb. 4 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.

FDA Warns Indian Drug Cos. of Continued Import Alert for CGMP Violations

February 6, 2015 |FDA

The Food and Drug Administration warned two Indian drug manufacturers that “serious” violations of current good manufacturing practice requirements could result in the agency continuing to refuse imports made at the two companies’ facilities. In letters dated Jan. 9 and Jan. 30, respectively, FDA listed the violations its inspectors found at Bangalore facilities run by Micro Labs Limited (here) and Apotex (here). FDA requested from each a “comprehensive evaluation” of data inaccuracy at the facilities, a risk assessment, and a management strategy including corrective action.

New and Revised FDA Import Alerts for Feb. 5

February 6, 2015 |FDA

On Feb. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Hamburg to Step Down as FDA Commissioner

February 6, 2015 |FDA

Margaret Hamburg will step down as Commissioner of the Food and Drug Administration at the end of March, according to a letter to agency staff posted to the FDA website (here). Hamburg, who has led the agency since 2009, will be succeeded by Stephen Ostroff, current FDA Chief Scientist, in an acting commissioner role.