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 Oct. 21

October 22, 2013 by Brian Feito|FDA

On Oct. 21 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Asks for Comments on Joint U.S.-EU-Japan Guidance on Drug Impurity Limits

October 22, 2013 by Brian Feito|FDA

The Food and Drug Administration is asking for comments by Dec. 23 on a new draft guidance on elemental impurities in pharmaceutical products. The draft guidelines (here), agreed to by the joint U.S.-European Union-Japan International Conference on Harmonization, would set safety limits for specific elements, and emphasizes control of supply chains and risk assessments, FDA said. The joint standard would set consistent expectations for test requirements and regulatory filings among the three ICH countries, said FDA.

New and Revised FDA Import Alerts for Oct. 18

October 21, 2013 by Brian Feito|FDA

On Oct. 18 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. 17

October 18, 2013 by Brian Feito|FDA

On Oct. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Long Beach Meeting on FDA's FSVP and Third-Party Audit Proposals Still Set for Oct. 22-23

October 18, 2013 by Brian Feito|FDA

The Food and Drug Administration will still hold its public meeting on the Foreign Supplier Verification Program and third-party auditor accreditation proposed rules in Long Beach, Calif., Oct. 22 and 23. The agency had to cancel a similar meeting Oct. 10-11 in Miami due to the federal government shutdown (see 13100803). FDA posted an agenda for the Long Beach meeting (here).

New and Revised FDA Import Alerts for Oct. 16

October 17, 2013 by Brian Feito|FDA

On Oct. 16 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. 15

October 16, 2013 by Brian Feito|FDA

On Oct. 15 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. 11

October 15, 2013 by Brian Feito|FDA

On Oct. 11 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. 10

October 11, 2013 by Brian Feito|FDA

On Oct. 10 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Warns Device Facilities in Canada, China and Japan for CGMP Violations

October 11, 2013 by Brian Feito|FDA

The Food and Drug Administration sent warning letters to device companies in Canada, China, and Japan, citing violations of current good manufacturing practice requirements at facilities owned by Batrik Medical (here), Anji Zhengbang Medical (here), and NIDEK (here), respectively. The letters, all sent between Sept. 19 and Sept. 24, gave each company 15 business days to fix the problems found during FDA inspections.