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 Threatens Germany Generic Drug Firm With Import Refusal for GDUFA Violations

October 4, 2013 by Brian Feito|FDA

The Food and Drug Administration threatened a German generic drug manufacturer with refusal of their imports at the border for failure to register and pay new fees required for generic drugs for fiscal year 2013. In a warning letter sent Sept. 17, FDA said C.P.M. Contract Pharma failed to comply with self-identification and facility fee requirements set by the Generic Drug User Fee Amendments of 2012. Because FY 2013 ended Sept. 30, FDA said it will not take enforcement action for failure to identify for that year if Contract Pharma completes its FY 2014 GDUFA self-identification submission within 15 days of receipt of the warning letter.

New and Revised FDA Import Alerts for Oct. 2

October 3, 2013 by Brian Feito|FDA

On Oct. 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 Oct. 1

October 2, 2013 by Brian Feito|FDA

On Oct. 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 Sept. 30

October 1, 2013 by Brian Feito|FDA

On Sept. 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 Sept. 27

September 30, 2013 by Brian Feito|FDA

On Sept. 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 Sept. 27

September 27, 2013 by Mike Feazel|FDA

On Sept. 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 Sept. 25

September 26, 2013 by Mike Feazel|FDA

On Sept. 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 Sept. 24

September 25, 2013 by Mike Feazel|FDA

On Sept. 24 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 Sept. 25

September 25, 2013 by Mike Feazel|FDA

On Sept. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

AAEI Says FDA Should Automatically Release Goods Upon Ok of NDA/BLA/ANDA

September 25, 2013 by Mike Feazel|FDA

Goods should, as a matter of policy, be automatically released from FDA detention upon approval of the New Drug Application/Therapeutic Biologic Application (BLA)/Abbreviated New Drug Approvals are approved, said the American Association of Exporters and Importers in comments on the FDA's Draft Guidance for Industry on Pre-Launch Activities Importation Requests (PLAIR) for drugs. AAEI also said importers should be allowed to distribute product as soon as the NDA/BLA/ANDA is approved, without additional FDA action, such as release from detention.