Search for: "Unite Here v. Food and Drug Administration"
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23 Apr 2014, 6:47 pm
Procedural HistoryGilead sued Natco Pharma Limited (“Natco”) for infringement of the ’483 patent after Natco filed a request with the Food and Drug Administration seeking approval to market a generic version of one of Gilead’s drugs that is allegedly covered by the ’483 patent. [read post]
18 Jan 2011, 11:58 am
Judge Corchado asked why this would not be an issue for the Food and Drug Administration (FDA). [read post]
23 Oct 2008, 9:03 am
In keeping with its plan of exclusive federal enforcement, Congress afforded the Food and Drug Administration ("FDA"), the responsible federal agency, a wide range of enforcement options. . . . [read post]
28 Mar 2013, 12:46 pm
Food and Drug Administration (FDA) reviewed your websites, www.polymva.com and www.polymva.net, as well as literature included in the information packet which accompanied the sale and shipment of your product, “Poly MVA” on November 15 and has determined that “Poly MVA” is promoted for conditions that cause the product to be a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21… [read post]
4 Sep 2014, 5:52 am
Food and Drug Administration said it would require device makers to submit new versions of the artificial hips for pre-market approval. [read post]
29 Jun 2021, 2:02 pm
District Court Judge Lynn Hughes the court upheld the Hospital’s mandatory vaccination policy that carved out narrow exceptions to employee-inoculation by any of the three vaccinations authorized on an emergency use basis by the United States Food and Drug Administration (“FDA”) based upon medical conditions or sincerely held religious beliefs. [read post]
16 Sep 2016, 8:30 am
MacPherson v. [read post]
13 Apr 2019, 12:25 pm
| Breaking: New referral to the Enlarged Board of Appeal on double-patenting Never Too Late 217 [Week ending 17 Feb] Further thoughts on Levola Hengelo v Smilde Foods and the taste of cheese: did the Court create a "validation" test? [read post]
3 Mar 2012, 6:48 am
If the warning or instruction given in connection with a drug or device or food or food additive has been approved or prescribed by the federal Food and Drug Administration …, a rebuttable presumption shall arise that the warning or instruction is adequate. [read post]
7 Feb 2019, 9:17 am
For an thought leader takaways here, and here.1. [read post]
12 Apr 2012, 6:02 pm
., a pharmacy that compounds veterinary drugs and whose bulk animal drug compounding activities were vindicated by a Florida federal district court last year, recently filed its Brief for the Appellees in the matter of United States v. [read post]
24 Mar 2023, 7:48 am
Department of Veterans’ Affairs and United States v. [read post]
6 Mar 2015, 12:53 pm
The Fredericksburg Care Company LP v. [read post]
22 Apr 2023, 3:32 am
Here is the opinion: Danco Laboratories v. [read post]
27 Jul 2023, 9:06 pm
Here is the law: 21 U.S.C. [read post]
10 Sep 2012, 2:07 pm
Here’s the language of the statute: Punitive damages shall not be awarded if a drug or device . . . which caused the claimant's harm was subject to premarket approval . . . by the federal Food and Drug Administration . . . and was approved . . . . [read post]
7 Oct 2022, 5:01 am
In Brown & Williamson, Justice O’Connor, writing for the court, found that the federal Food and Drug Administration (FDA) lacked power to regulate cigarettes. [read post]
14 Aug 2018, 11:38 am
In Coalition for Mercury-Free Drugs v. [read post]
14 Jul 2016, 2:37 pm
Food and Drug Administration requirements. [read post]
14 Nov 2016, 9:16 am
King Drug Company of Florence, Inc., et al., No. 15-1055 (antitrust reverse payment – appeal from the 3rd Cir.) 3. [read post]
