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21 Feb 2014, 8:53 am
§ 201.57(c)(18) (requiring all “FDA-approved patient labeling” to appear in the “Patient counseling information” section of drug labeling).We added all this emphasis to underscore the point that requiring a medication guide – as distinguished from what it might say − is another of those decisions that requires FDA pre-approval. [read post]
8 Jan 2014, 10:03 am by Joel R. Brandes
 It remanded the cause for further proceedings,  including a determination of whether to award costs to Hollis.Philip C. [read post]
26 Dec 2013, 1:27 pm
The Problem: Though the language of the opinion is couched in the technical language of statutory interpretation, the underlying conceptual issues and choices among structuring premises make the case far more interesting, and important. [read post]
2 Dec 2013, 4:47 am
Courts are not required to accept as true legal conclusions couched as factual allegations. [read post]
20 Nov 2013, 3:07 pm
  Turning to the example above, a core comprising a mixture of binder polymers A and B, would not be "the same" as a shell comprising a mixture of binder polymers B and C,  because of the presence of A and C in the core and shell, respectively. [read post]
1 Nov 2013, 7:19 pm by Robin E. Shea
#firstworldproblems/#solutions And here are a couple of real ones from Twitter that I thought were pretty funny:   <blockquote><p>I left my remote on the other couch <a href="https://twitter.com/search? [read post]
23 Oct 2013, 9:21 am by Dan Goodin
In an age when smartphones are nearly ubiquitous, people can crank up the heat, record TV programs, and check home-security systems without getting off the couch or leaving the little league game that's gone into extra innings. [read post]
10 Sep 2013, 11:20 pm by Buce
  I'm not sure whether (a) women here are more complaisant; or (b) men or better behaved or (c) women here despair of ever improving men's behavior. [read post]
29 Jul 2013, 7:34 am by Adam Kielich
Couch the negotiation in terms of “your value” rather than dollars and cents. [read post]
10 Apr 2013, 4:08 pm by Stephen Bilkis
The complaint is couched in the traditional language of a legal malpractice case. [read post]
3 Apr 2013, 7:43 pm
 This is the process which is currently underway in Case C-65/12 Leidseplein Beheer, in which Advocate General Kokott's Opinion was published online on 21 March 1013 in various official languages of the European Union, but not in English. [read post]
31 Mar 2013, 9:36 pm by Ken
If Judge Wright makes a referral couched in the sort of blunt language he has uttered to date, he'll probably inspire immediate and vigorous State Bar investigations of the named lawyers. [read post]
12 Feb 2013, 1:23 pm by WIMS
Vitol's allegations are conclusory and contain legal conclusions couched as factual allegations. [read post]