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6 Sep 2011, 4:00 pm by FDABlog HPM
  But even if so, FDA cannot make the same case for § 505(b)(2) drugs because the elements of a TE evaluation cannot be found in § 505(b)(2) (or any other statutory provision applicable to § 505(b)(2) drugs). [read post]
19 Jul 2012, 3:21 am
Jackson, Perfidy in Non-International Armed Conflicts Raymundo B. [read post]
23 Dec 2007, 6:26 am
(Thomas, J.), the court was faced with the issue of the appropriate date on which to measure the exchange rate from Canadian dollars into United States dollars in the determination of a creditor's claim. [read post]
11 Oct 2016, 5:13 am
  Henderson J noted that this was a highly fact-specific issue which was unlikely to be suitable for summary determination. [read post]