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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 Asks for Comments on Drug Administrative Detention Authority
April 8, 2013 by Jessica Arriens|FDA

The Food and Drug Administration is soliciting public comments on new regulations that will give the agency administrative detention authority with respect to drugs. The authority is granted to FDA under the Food and Drug Administration Safety and Innovation Act (FDSIA), signed into law by President Obama July 2012 (see 12062727). Section 709 of that law alters the Federal Food, Drug and Cosmetic Act -- which gives FDA administrative detention authority for food, tobacco products and devices -- by adding drugs to that list of items.

FDA Planning 3-Day Conference on Global Regulatory Environment
April 4, 2013 by Mike Feazel|FDA

The Food and Drug Administration and the Parenteral Drug Association plan a public conference on "Driving Quality and Compliance Throughout the Product Life Cycle in a Global Regulatory Environment," according to a Federal Register notice. The conference will explore ways to ensure conformance with regulations that facilitate improvement of safe and effective medical products, it said. The all-day conference will begin at 7 a.m. Sept. 16 and continue through Sept. 18 at the Renaissance Washington Hotel in Washington, D.C. Further information: Wanda Neal, 301-656-5900, ext. 111 or info@pda.org.

FDA Proposes to Require PMAs for Three Devices
April 4, 2013 by Brian Feito|FDA

The Food and Drug Administration is proposing to require premarket approval for three devices: sorbent hemoperfusion devices for treatment of hepatic coma and metabolic disturbances; cranial electrotherapy stimulators for treatment of depression, anxiety, and insomnia; and transilluminators for breast evaluation. Should FDA finalize its proposed order, a pre-market approval (PMA) application or notice of development of product development protocol (PDP) will be required before commercial distribution of these class III devices. Comments on the proposed order are due by May 6. The PMA requirements would be effective 90 days from issuance of the final order.