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4 Mar 2009, 2:31 am
[JURIST] The US Supreme Court [official website; JURIST news archive] ruled [opinion, PDF] 6-3 Wednesday in Wyeth v. [read post]
6 Oct 2008, 8:50 am
[JURIST] The US Supreme Court [official website; JURIST news archive] heard oral arguments Monday in three cases, including Altria Group v. [read post]
27 Aug 2012, 5:38 am
Reynolds Tobacco Co. v. [read post]
20 Feb 2010, 12:41 am
(The off-label use at issue in the case is the treatment of spasmodic dysphonia; although Botox is most widely known for cosmetic uses, it is on-label for treating certain conditions associated with cervical dystonia, severe primary axillary hyperhidrosis, and strabismus and blepharospasm associated with dystonia.) [read post]
2 Mar 2015, 8:13 am
McDowell v. [read post]
15 Jan 2009, 5:14 am
Epogen & Aranesp Off-Label Marketing & Sales Practices Litigation, 2008 WL 5335062, at *7 (C.D. [read post]
6 Jan 2009, 12:26 pm
On December 15, 2008, the United States Supreme Court issued a decision in Altria Group, Inc. v. [read post]
18 Dec 2023, 9:07 pm
§ 355(j)(2)(A)(viii) (the so-called "skinny label) has in the recent past raised something of a kerfuffle before the Federal Circuit (see "GlaxoSmithKline LLC v. [read post]
6 May 2014, 10:02 pm
Supreme Court in Central Hudson Gas and Electric Corp. v. [read post]
20 Jul 2021, 9:04 am
In TransUnion v. [read post]
18 Dec 2023, 10:00 pm
Hear expert commentary from Tom Irving and Michelle O’Brien of the Marbury Law Group on the risk generic drug companies face when utilizing a skinny label in the aftermath of the Federal Circuit’s decision in Glaxosmithkline LLC v. [read post]
12 Oct 2010, 6:50 am
Adler) Last month, in International Dairy Foods Association v. [read post]
EPA Releases Draft Guidance for Pesticide Registrants on Plant Regulator Label Claims, Including Pla
27 Mar 2019, 7:46 am
“Product label claims generally considered ‘non-pesticidal’ (i.e. non-plant regulator claims),” including: “plant nutrition-based claims” (Table 1a); “plant inoculant-based claims” (Table 1b); and “soil amendment-based claims” (Table 1c): “Generic product label claims for products not covered by the exclusions in the FIFRA Section 2(v) definition of a plant regulator,” including “examples… [read post]
8 Jul 2013, 1:35 pm
If the F.D.A. agrees that the label change is necessary, the generic manufacturers of the drug must also change their labels. [read post]
22 Jun 2021, 4:59 pm
In Bailey v. [read post]
2 Jul 2015, 11:34 am
United States v. [read post]
2 Jul 2015, 12:29 pm
United States v. [read post]
23 Mar 2015, 2:56 pm
Opinion, Reid v. [read post]
3 Nov 2008, 3:51 am
Oral argument in the big preemption case of the Supreme Court Term, Wyeth v. [read post]
30 Apr 2014, 9:39 am
Case citation: POM Wonderful LLC v. [read post]
