November 2010 Archives

Petition for Review of Nuclear Regulatory Commission's Order

In Shieldalloy Metallurgical Corp. v. Nuclear Reg. Comm'n, No. 09-1268, a petition for review of the Nuclear Regulatory Commission's (NRC) transfer of regulatory authority to New Jersey, that New Jersey's nuclear energy program was incompatible with the federal scheme and that the transfer of authority was arbitrary and capricious, the court granted the petition where the NRC should have explained how petitioner's decommissioning process could proceed under the New Jersey regime free of the interference and interruption sought to be avoided by the NRC's Criterion 25 and why the partial transfer was not an appropriate alternative arrangement.

Petition for Review of FDA Order

In Actavis Elizabeth LLC v. FDA, No. 10-5066, a petition for review of the FDA's order that Vyvanse, a name-brand drug for the treatment of attention deficit hyperactivity disorder (ADHD), was entitled to five years of marketing exclusivity, the court affirmed summary judgment for defendants where 1) since lisdexamfetamine contained an amide bond, the FDA properly treated it as an "active moiety" of its own; and 2) given the complexity of the statutory regime, the court deferred to the agency's interpretation.