Search for: "Unite Here v. Food and Drug Administration" Results 201 - 220 of 445
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20 Oct 2011, 2:30 pm by FDABlog HPM
  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]
3 Sep 2014, 9:00 am by Maureen Johnston
Plaintiffs’ Legal Committee, the Federal Food, Drug, and Cosmetic Act impliedly preempts a private state-law claim for unfair competition premised on a party’s purported failure to obtain Food and Drug Administration approval, where the Food and Drug Administration itself has not imposed any such requirement. [read post]
2 Jan 2024, 4:57 am by Marcia Coyle
The justices have not yet scheduled an argument date for Food and Drug Administration v. [read post]
23 Feb 2009, 2:41 am
The stent had not been approved by the Food and Drug Administration when implanted. [read post]
22 Apr 2023, 5:08 am by Will Baude
The Food and Drug Administration (FDA) has engaged in what has become the practice of "leverag[ing]" district court injunctions "as a basis" for implementing a desired policy while evading both necessary agency procedures and judicial review. [read post]
2 Jun 2014, 8:55 am by WIMS
Food and Drug Administration launched open FDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. [read post]
17 Jun 2014, 7:15 am by Maureen Johnston
Stengel 12-1351Issue: Whether the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act preempt a state-law claim alleging that a medical device manufacturer violated a duty under federal law to report adverse-event information to the Food and Drug Administration. [read post]
11 Sep 2012, 11:36 am by Bexis
Statutory immunity does not apply, however, if the manufacturer or seller:  (a) Intentionally withholds from or misrepresents to the FDA information concerning the drug that is required to be submitted under the FDCA, and the drug would not have been approved, or the FDA United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted, or (b) Makes an illegal payment… [read post]
12 Jan 2012, 7:59 am
Food & Drug Administration (FDA) voted to recommend by 15-11 margin that the benefits of Yaz, Yasmin and similar pills made with the synthetic progestin, drospirenone, outweighed their risk of dangerous blood clots. [read post]
13 Oct 2014, 9:01 am by Lyle Denniston
Since then, no generic company has gained approval by the Food and Drug Administration to market a generic version of the drug, although the FDA in August agreed to review a new application from one of the generic firms — Momenta Pharmaceuticals, Inc. [read post]
6 Sep 2018, 8:03 am by Joy Waltemath
Seen by the administration as a limitation on states’ ability to require those who apply for unemployment benefits to submit to drug testing, that rule established, for state unemployment compensation program purposes, occupations that regularly conduct drug testing. [read post]
1 Jul 2019, 9:03 pm by Guest Contributor
Food and Drug Administration’s (FDA) Coordinated Outbreak Response and Evaluation (CORE) network (2013-2017). [read post]
11 Feb 2015, 12:23 pm
Its investigation determined that Bayer was not selling in the product in the US, had not filed for US trade mark protection and had not listed its product with the US Food and Drug Administration (FDA). [read post]
5 Jul 2013, 5:00 am by Bexis
Quintana, 827 P.2d 509, 525 (Colo. 1992) (“[defendant’s] compliance with the Food and Drug Administration’s recommendations . [read post]
31 Aug 2012, 2:43 pm by Bexis
”  Id. at 2502-03 (describing Buckman holding as “States may not impose their own punishment for fraud on the Food and Drug Administration”). [read post]
20 Nov 2020, 3:44 pm by Jonathan H. Adler
In any event, Plaintiffs have no authority to challenge the Food and Drug Administration's decision not to enforce the FDCA in this context. [read post]