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 Issues First Warning Letter for Drug Supply Chain Law Violations

February 12, 2019 |FDA

The Food and Drug Administration recently issued its first warning letter for violations under the Drug Supply Chain Security Act, FDA Commissioner Scott Gottlieb said in a Feb. 12 statement. McKesson Corp., a U.S. distributor of pharmaceuticals, was cited for its failure to sufficiently respond to notifications from a pharmacy it supplied that there was illegitimate product in its supply chain -- opioid pills were missing from bottles that were distributed by McKesson -- and did not quarantine and investigate suspect products or maintain records of investigations of suspect product, Gottlieb said. “We’ll continue our efforts to help ensure manufacturers, repackagers, wholesale distributors, dispensers and others responsible for maintaining the supply chain are taking measurable steps under the law to appropriately track and trace medications -- including opioids -- as they move through the supply chain, and to respond to incidents involving illegitimate products in order to protect the public health,” Gottlieb said.

New and Revised FDA Import Alerts for Feb. 8

February 11, 2019 |FDA

On Feb. 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 Feb. 7

February 8, 2019 |FDA

On Feb. 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 Feb. 6

February 7, 2019 |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. 6

February 7, 2019 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Feb. 6 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.

FDA Begins DSCSA Pharmaceutical Supply Chain Electronic Tracing Pilot Program

February 7, 2019 |FDA

The Food and Drug Administration is announcing the beginning of a new pilot program to test product tracing required under the Drug Supply Chain Security Act. Participants, including drug manufacturers, wholesale distributors and “other supply chain stakeholders,” will develop pilots to test out electronic product tracing at the package level required under DSCSA by 2023. FDA may begin more than one pilot associated with the effort, and each will require periodic progress reports and a final report by participants.

New and Revised FDA Import Alerts for Feb. 5

February 6, 2019 |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:

New and Revised FDA Import Alerts for Feb. 1

February 4, 2019 |FDA

On Feb. 1 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 Jan. 31

February 1, 2019 |FDA

On Jan. 31 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 Jan. 30

January 31, 2019 |FDA

On Jan. 30 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: