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17 Apr 2010, 2:59 am
Court of Appeals for the 2nd Circuit.In Peconic Baykeeper v. [read post]
16 Nov 2011, 5:18 pm by FDABlog HPM
  For starters, Hill alleges that contrary to the statutory requirement at FDC Act § 505(j)(2)(A)(v) that the labeling for a generic drug be “the same” as the labeling approved for the brand-name, reference listed drug relied on for approval, “the generic forms of fluocinolone acetonide that FDA has approved will almost certainly include labeling that is substantially different from the labeling used on Hill’s products. [read post]
8 Jun 2023, 12:22 am by Bill Marler
In addition to the Illinois patients, there are patients in other states, but the Illinois officials did not report what states are involved. [read post]
29 Oct 2012, 11:36 am by John J. Sullivan
  It’s kind of appropriate, though, because the court’s opinion n Lateef v. [read post]