Search for: "Unite Here v. Food and Drug Administration"
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25 Apr 2023, 8:00 am
Here is the law: 21 U.S.C. [read post]
25 Jul 2023, 4:44 pm
Here is the law: 21 U.S.C. [read post]
6 Jun 2011, 6:12 am
Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to competing products.South Carolina’s lawyers argued during a two-week trial of the state’s suit that Risperdal’s safety label also downplayed diabetes and other health risks. [read post]
28 Feb 2007, 5:55 pm
United States v. [read post]
30 Dec 2016, 1:27 pm
We'll be here to keep you posted! [read post]
15 Apr 2014, 9:29 am
As it happens, the federal Food, Drug, and Cosmetic Act (“FDCA”) regulates many aspects of food sales and marketing, including product labels. [read post]
15 Jan 2015, 9:57 am
Kurtz v. [read post]
22 Mar 2011, 5:08 am
Food and Drug Administration responded with a warning letter saying J&J made false and misleading claims that minimized the potentially fatal risks of diabetes and overstated the drug’s superiority to those from competitors.J&J contends the state hasn’t proved the company set out to mislead doctors about Risperdal or started a “spin campaign” to bolster sales of the drug, Steven J. [read post]
30 Dec 2016, 1:27 pm
We'll be here to keep you posted! [read post]
2 Sep 2017, 9:00 am
Here are basic steps you can take to work through the puzzle. [read post]
24 Apr 2017, 11:12 am
The imprecision, however, creates a regulatory problem because the Food and Drug Administration must approve any new drug before it is sold. [read post]
25 Jun 2009, 4:29 am
We've been all over this issue, here, here, here, and here, from the moment Twombly was first decided two years ago.While we've naturally concentrated on how the heightened standard affects plaintiffs, it's possible that our side might have to - or, more likely, want to - plead more FDA-related allegations in support of our defenses. [read post]
26 Oct 2010, 7:19 pm
Judge Richard Seeborg explained that the Food Drug and Cosmetics Act preempted the state law false advertising claims with regard to nutrition claims and they lacked standing to pursue the Lanham Act claim. [read post]
20 Mar 2014, 5:34 pm
Food and Drug Administration (the “FDA”), seeking approval to manufacture, use, and sell an ophthalmic travoprost solution as a generic version of Travatan Z®. [read post]
24 Sep 2015, 5:24 am
The relevant FDA regulation requires that device manufacturers “must submit a premarket notification submission to the Food and Drug Administration at least 90 days before” beginning to sell the modified device: that the person currently has in commercial distribution . [read post]
4 Jul 2023, 11:59 am
La.) is here, and the injunction is here. [read post]
3 Mar 2008, 7:05 am
The lawsuit is based in part on a claim that fraud had led the Food and Drug Administration to approve the drug. [read post]
19 Dec 2013, 6:12 am
A specific warning relating to a use not provided for under the “Indications and Usage” section of the labeling may be required by the Food and Drug Administration if the drug is commonly prescribed for a disease or condition, and there is lack of substantial evidence of effectiveness for that disease or condition, and such usage is associated with serious risk or hazard.21 C.F.R. [read post]
19 Sep 2008, 7:13 am
Bates v. [read post]
20 Oct 2011, 2:30 pm
Par Pharmaceuticals recently challenged (here and here) FDA’s authority in the off-label promotion arena on First Amendment and Administrative Procedure Act grounds. [read post]
