Search for: ""Wyeth v. Levine" OR "555 U.S. 555"" Results 21 - 40 of 73
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4 Sep 2014, 12:42 pm
Levine, 555 U.S. 555 (2009), an implied preemption drug case, in opposition to “different from or in addition to” express preemption under the Medical Device Amendments. [read post]
22 Aug 2014, 9:22 am
Levine, 555 U.S. 555 (2009), impossibility preemption did not apply to innovator prescription drugs because simultaneous compliance with FDA and state tort law labeling obligations was possible due to the “changes being effected” (“CBE”) exception allowing updated warnings without prior FDA approval. [read post]
15 Aug 2014, 12:54 pm
Levine, 555 U.S. 555, 570-71 (2009), about innovator manufacturer’s “responsibility” for their labels, ends up stating that “the FDA has the responsibility of weighing (in terms of extremes) the potential benefit of lifesaving medication against potential severe side effects. [read post]
12 Jun 2014, 10:46 am
Levine, 555 U.S. 555 (2009), in that Congress could have included some limitation provision in the 70+ years that both statutes have been on the books. [read post]
22 May 2014, 5:00 am
Levine, 555 U.S. 555, 578 n.11 (2009) (FDA “has limited resources,” which “are inadequate to permit the discharge of its existing responsibilities”), the FDA is not known to be free with exceptions to its Touhy regulation. [read post]
3 Feb 2014, 5:00 am
Levine, 555 U.S. 555 (2009), and weaponized by our side in PLIVA v. [read post]
31 Oct 2013, 5:00 am
Levine, 555 U.S. 555 (2009)) innovator drug processes. [read post]
5 Sep 2013, 12:24 pm by Bexis
Levine, 555 U.S. 555 (2009) – we took a look.Hmmmm.For a post-Levine decision, we actually don’t think the rulings are all that bad. [read post]
25 Jul 2013, 5:00 am by Bexis
Levine, 555 U.S. 555 (2009)) or not (as in Bartlett and Mensing) the defendant drug manufacturer can change its label without prior FDA approval. [read post]