Search for: "Unite Here v. Food and Drug Administration"
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16 Oct 2009, 3:18 pm
Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. [read post]
9 Dec 2010, 8:13 am
The department still hasn't received the shipment, which is being held on the East Coast awaiting clearance from the Food and Drug Administration, spokeswoman Terry Thornton said. [read post]
26 Jun 2013, 12:21 pm
One of the exceptions to this bar on liability is where:the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the United States Food and Drug Administration; the product was used as recommended, promoted, or advertised; and the claimant's injury was causally related to the recommended, promoted, or advertised use of the product. [read post]
6 Jun 2020, 9:26 pm
By then, U.S, Food and Drug Administration (FDA) inspectors had arrived at the ice cream factories, finding evidence of poor sanitation and deteriorating plant and equipment that was not being sufficiently cared for or cleaned. [read post]
28 Jul 2021, 4:42 pm
Healthcare The Order (i) directs the Food and Drug Administration (FDA) to work with states and tribes to safely import prescription drugs from Canada, pursuant to the Medicare Modernization Act of 2003; (ii) directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, which can provide low-cost options for patients; (iii) directs HHS to issue a comprehensive plan within 45 days to combat high… [read post]
12 Dec 2007, 2:33 pm
The exception is limited to a manufacturer that:Intentionally withholds from or misrepresents to [FDA] information concerning the drug that is required to be submitted under the federal Food, Drug, and Cosmetic Act, and the drug would not have been approved, or [FDA] would have withdrawn approval for the drug if the information were accurately submitted.Mich. [read post]
19 Sep 2023, 3:34 am
Specifically, the statute would be amended to require NDA sponsors to: (i) certify to the Food and Drug Administration that the information described in subparagraph (B) that is submitted to the Secretary is complete and consistent with the information such sponsor or holder provided to the United States Patent and Trademark Office and any communications such sponsor or holder had with the United States Patent and Trademark Office; and (ii) (I)… [read post]
3 Jan 2008, 7:22 am
The legal issue is now whether the injured patient is deprived of a legal remedy simply because the Food and Drug Administration had approved the device for use. [read post]
4 Aug 2019, 1:26 pm
” Just after 8 AM, he discharged Mikayla from the ER with a prescription for an antiemetic drug and clearance to travel to Costa Rica. [read post]
8 Jul 2014, 6:59 am
While means of contraception are not specifically referenced in the ACA, under regulations issued by the Obama administration the term preventive care was interpreted to include all contraception and sterilization measures approved by the United States Food And Drug Administration, including birth-control pills, intrauterine devices and the morning-after pill. [read post]
9 Jan 2014, 1:37 pm
Here’s another:[T]he proliferation of label detail threatens to undermine the effectiveness of warnings altogether. [read post]
15 May 2019, 3:54 am
Notes 1 United Cannabis Corp. v. [read post]
7 Apr 2023, 4:25 pm
Here is the law: 21 U.S.C. [read post]
27 Dec 2021, 10:05 pm
Appx. 774 (9th Cir. 2012) (“USDA responded to the Hornes’ rulemaking petition—as it must under the Administrative Procedure Act”); WWHT, Inc. v. [read post]
22 May 2014, 5:00 am
The FDA’s regulation is one which ordinarily tells private litigants, in effect, to pound sand:(a) No officer or employee of the Food and Drug Administration or of any other office or establishment in the Department of Health and Human Services, except as authorized by the Commissionerof Food and Drugs pursuant to this section or in the discharge of his official duties under the laws administered by the Food and Drug… [read post]
8 Sep 2016, 10:00 pm
Food and Drug Administration were over years ago. [read post]
29 May 2009, 7:14 am
The Food and Drug Administration has recognized that acetaminophen poisoning is a public health issue and has slowly taken steps to educate the public to this popular drug's dangers. [read post]
25 Apr 2024, 9:46 am
” Of course, Silbersher might respond here that the way for Valeant to avoid lawsuits was to not commit (alleged) fraud on the United States. [read post]
9 Apr 2013, 7:28 pm
Plaintiff Scott Miller allegedly bought a package of “Ghirardelli® Chocolate Premium Baking Chips –Classic White” and then, on behalf of himself and other consumers, sued the Ghirardelli Chocolate Company, complaining that defendant somehow deceived customers into thinking that this and four other products contained “artificial” or “imitation” ingredients, in violation of United States Food and Drug Administration… [read post]
1 Mar 2007, 4:57 am
Von Eschenbach:Public Citizen, representing more than 100,000 consumers nationwide, hereby petitions the Food and Drug Administration (FDA) pursuant to the Federal Food, Drug and Cosmetic Act 21 U.S.C. [read post]
