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24 Sep 2011, 2:59 am
Food and Drug Administration announced Friday.Soliris (generically eculizumab), marketed in this country by Alexion Pharmaceuticals, will for now be allowed only to treat patients with atypical hemolytic uremic syndome (aHUS), which accounts for 5 to 10 percent of all cases of HUS, an acute condition that disproportionately affects children.But the fast-track approval by the FDA for the use of Soliris to treat atypical HUS, and to use it to treat… [read post]
26 Jun 2009, 1:26 pm
Marshals responded to a directive from the Food and Drug Administration (FDA) ordering the seizure of drugs from Caraco Pharmaceutical Laboratories, Ltd.'s facilities in Detroit, Farmington Hills and Wixom. [read post]
4 Nov 2019, 9:01 pm
The Food and Drug Administration is currently considering adding sesame to the list of allergens requiring discloser on food labels. [read post]
12 Oct 2010, 4:56 pm
Last week, the Food and Drug Administration announced that it was recalling the anti-obesity drug Meridia, manufactured by Abbott Laboratories from the American market. [read post]
1 Apr 2010, 2:59 am
Use of this drug in this manner is extra-label use. [read post]
23 Dec 2009, 4:00 am
According to a nj.com article, a long-awaited bill proposed by the Senate to overhaul the food safety system set forth by the Food and Drug Administration has been unanimously approved. [read post]
8 Feb 2022, 6:59 am
Food and Drug Administration the authority to regulate synthetic nicotine products. [read post]
17 Aug 2016, 8:22 am
Food & Drug Administration (FDA) doesn’t approve of marijuana or any derivative drug to treat these conditions. [read post]
28 Aug 2019, 9:01 pm
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. [read post]
6 Sep 2022, 7:07 pm
Popular Science: “Over Labor Day weekend, pharmacies across the country began receiving shipments of new Omicron- specific mRNA booster shots against COVID-19, after the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) signed off on their use last week. [read post]
28 Sep 2015, 5:05 pm
The Food and Drug Administration (FDA) has yet to issue formal regulations and policies on the labeling of GE food. [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
29 Jun 2022, 2:00 am
J. (2022): This Article argues that the Food and Drug Administration (“FDA”) should regulate drug manufacturer speech about off-label uses based on the evidentiary support for the relevant use. [read post]
24 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE). [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
24 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE). [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
19 Dec 2023, 10:00 pm
As the close of 2023 approaches, the US Food and Drug Administration (FDA) has issued draft guidance detailing its new Advanced Manufacturing Technologies Designation Program, intended to facilitate the development and accelerate the review of drugs and biological products manufactured using an advanced manufacturing technology (AMT) that has been designated under the program. [read post]
24 Mar 2024, 10:00 pm
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the demonstration of substantial evidence of effectiveness and/or evidence of safety of a drug or biologic, as another chapter in its evolution toward the use of real-world evidence (RWE). [read post]
