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 to Hold Hearing on Planned Changes to National Drug Code Format

August 13, 2018 |FDA

The Food and Drug Administration will hold a public hearing Nov. 5 to discuss planned changes to the format of national drug codes, it said in a notice. The agency will sometime in the future begin issuing 11-digit NDCs once it runs out of the five-digit drug labeler codes that make up a portion of NDCs. FDA anticipates that will happen in about 15 years. The hearing will include discussion of how a change to 11-digit codes will impact the pharmaceutical supply chain, as well as issues related to the current lack of uniformity among NDCs. Written comments are due by Jan. 5, 2019.

New and Revised FDA Import Alerts for Aug. 9

August 10, 2018 |FDA

On Aug. 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 Aug. 8

August 9, 2018 |FDA

On Aug. 8 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. 7

August 8, 2018 |FDA

On Aug. 7 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. 3

August 6, 2018 |FDA

On Aug. 3 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. 2

August 3, 2018 |FDA

On Aug. 2 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. 1

August 2, 2018 |FDA

On Aug. 1 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. 1

August 2, 2018 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 1 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

New and Revised FDA Filer Evaluation Outcomes for August

August 2, 2018 |FDA

The Food and Drug Administration posted its updated list of filer evaluation outcomes for August 2018. The frequency of filer evaluations depends on the number of lines filed by the company. An outcome of "paperless" means FDA has determined that electronic filing is appropriate, while "corrective action plan" means FDA has found an elevated error rate and has directed the filer to fix the issue, and "dual-mode filer" means the company has failed to implement corrective action plans and has been returned to dual-mode (paper and electronic) filing. The following filer evaluation outcomes were updated in FDA's August 2018 list:

New and Revised FDA Import Alerts for July 31

August 1, 2018 |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: