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10 Dec 2010, 3:16 pm by FDABlog HPM
Wyeth, Inc.], abrogated the Hatch-Waxman Amendments by allowing state tort liability for failure to warn in direct contravention of the Act’s requirement that a generic drug’s labeling be the same as the FDA-approved labeling for the listed (or branded) drug. [read post]
10 Sep 2008, 12:20 pm
Instead, the United States alleges precisely what is required by § 2318, that is, that the Defendant knowingly trafficked in illicit labels. [read post]
17 Sep 2013, 12:28 pm by Priscilla Smith
Carhart, and its decision earlier this summer in United States v. [read post]
4 Feb 2009, 3:31 am
  Here in SHAHRAM DAVID LAVIAN,  -v.- IRA DANIEL TOKAYER, ESQ., 08 Civ. 938 (PAC) (GWG); UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF NEW YORK;2009 U.S. [read post]
24 Dec 2015, 8:20 am
  That such labeling might be a “floor” for preemption purposes, as the court stated, was totally irrelevant because preemption was not an issue. [read post]
29 Oct 2012, 9:30 am by Ken Gibson
You would think the alcohol would show up on a label, but federal law only requires the ethanol content to be reported or labeled if the alcohol content is .5% w/v or greater. [read post]