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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 Proposes Changes to Laser Standard
June 21, 2013 by Brian Feito|FDA

The Food and Drug Administration is proposing amendments to its performance standard for laser products. FDA said the changes would harmonize its requirements with the International Electrotechnical Commission’s standards for laser products and medical laser products. It would also “reduce the economic burden on affected manufacturers,” and better protect public health, FDA said. Any final rule implementing the changes would not be effective until at least two years after publication, FDA said. Comments on FDA’s proposal are due by Sept. 23.

EU Exempts U.S. APIs From Export Certification Requirements
June 21, 2013 by Brian Feito|FDA

Exporters of active pharmaceutical ingredients to the EU will avoid burdensome certification requirements, after the European Commission declared the U.S. a “listed” country June 21 (here). Without the waiver, all U.S. companies shipping APIs to Europe after July 1 would have had to first submit documentation from the Food and Drug Administration that the product was manufactured in accordance with Europe’s good manufacturing practices, FDA said.

FDA to Gather Input on Drug Import Regs at July 12 Meeting
June 18, 2013 by Claire Yan|FDA

The Food and Drug Administration will hold a meeting on implementation of certain provisions of the Food and Drug Administration Safety and Innovation Act, including standards for admission of imported drugs and commercial drug importers. The July 12 meeting in Silver Spring, Md., will include a general overview on FDASIA's Title VII supply chain integrity protections. FDA will also ask for input on the types of information that importers should be required to provide as a condition of admission, as well as registration requirements for commercial drug importers and good importer practices.