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Page "Food and Drug Administration" ¶ 2
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FDA and is
This task force aims to actively address antimicrobial resistance, and is coordinated by the US Centers for Disease Control and Prevention, the Food and Drug Administration ( FDA ), and the National Institutes of Health ( NIH ), as well as other US agencies.
Hydroxyzine ( Atarax ) is an old antihistamine originally approved for clinical use by the FDA in 1956.
There is a genetically altered salmon with an increased growth rate being considered for FDA approval.
The Food and Drug Administration ( FDA ) is the principal healthcare regulatory authority in the United States, having jurisdiction over medical devices, drugs, biologics, and combination products.
( Pine tar has historically also been used for this purpose, but has been banned as a medical product by the FDA, since no evidence was submitted proving it is effective.
According to the National Psoriasis Foundation and the FDA, coal tar is a valuable, safe and inexpensive treatment option for millions of people with psoriasis and other scalp or skin conditions.
Used to treat obesity in persons with a BMI ( body mass index ) of 30 or above, as well as for smoking cessation treatments, Acomplia is still pending FDA approval for use in the United States.
The efficacy of the RNS is under current investigation with the goal of FDA approval.
The Food and Drug Administration ( FDA or USFDA ) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments.
The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs ( medications ), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices ( ERED ), and veterinary products.
Much of the expenditures is for goods imported into the United States ; the FDA is responsible for monitoring a third of all imports.
In 1956 the FDA had moved for the burning of William Reich's books and research materials, which is seen as one of the worst examples of censorship in U. S. history.
* It is hard to get U. S. FDA approval to treat a pre-symptomatic condition because it is hard to predict the complications that may arise, so it is hard to give a risk / benefit analysis.
The FDA study concluded: "... steps such as heat, alkaline treatment, and filtration could be effective in reducing the level of contaminating TSE agents ; however, scientific evidence is insufficient at this time to demonstrate that these treatments would effectively remove the BSE infectious agent if present in the source material.
It is in FDA pregnancy category C. Animal reproduction studies have shown an adverse effect on the fetus, and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This restriction is only limited by the fact that twelve tablets, each containing 325 mg of paracetamol, puts the patient right below the 24-hour FDA maximum of 4, 000 mg of paracetamol.
FDA is currently proposing a rule that in some cases would allow certain irradiated foods to be marketed without any labeling at all.
In the same rule FDA is proposing to permit a firm to use the terms " electronically pasteurized " or " cold pasteurized " in lieu of " irradiated ", provided it notifies the agency that the irradiation process being used meets the criteria specified for use of the term " pasteurized ".
Food irradiation in the United States is primarily regulated by the FDA since it is considered a food additive.
The Radura logo as regulated by FDA is slightly different from the international version as proposed in Codex Alimentarius.

FDA and led
This led the CDC and FDA to issue a joint order banning the sale, trade, and transport within the United States of prairie dogs ( with a few exceptions ).
This led to the launch of the first soft ( hydrogel ) lenses in some countries in the 1960s and the first approval of the Soflens material by the United States Food and Drug Administration ( FDA ) in 1971.
The principal breakthrough in soft lenses made by Otto Wichterle led to the launch of the first soft ( hydrogel ) lenses in some countries in the 1960s and the approval of the " Soflens " daily material ( polymacon ) by the United States FDA in 1971.
In 2009, the Food and Drug Administration ( FDA ) approved the use of microwave energy for producing pre-packaged, low-acid foods, and WSU professor Juming Tang led development of the technology by university, industry and U. S. military scientists.
A Canadian-led Phase III randomised controlled trial, reported in 2005, involved 569 patients with advanced pancreatic cancer, led the US FDA in 2005 to license erlotinib ( Tarceva ) in combination with gemcitabine as a palliative regimen for pancreatic cancer.
Lilly, American Cyanamid, and Upjohn, and Monsanto all submitted applications to market rBST to the FDA, and the FDA completed its review of the human safety component of the these applications in 1986 and found food from rBST-treated cows to be safe ; however strong public concern led to calls for more studies, investigations, and public discussions, which included an unprecedented conference on the safety of rBST in 1990 organized by the NIH at the request of Sen. Patrick Leahy.
Likewise, association of the related appetite suppressant phenylpropanolamine with hemorrhagic stroke led the Food and Drug Administration ( FDA ) to request its withdrawal from the market in the United States in 2000, and similar concerns regarding ephedrine resulted in an FDA ban on its inclusion in dietary supplements, in 2004 ( a Federal judge later overturned this ban in 2005 during a challenge by supplement maker Nutraceuticals ).
This has led to the FDA and other bodies to takes steps to investigate these concerns.
His illness and eventual death also led to a heightened awareness of the dangers of ingesting radioactive materials, and to the adoption of laws that increased the powers of the FDA.

FDA and by
In March, 2012 the United States District Court for the Southern District of New York, ruling in an action brought by the Natural Resources Defense Council and others, ordered the FDA to revoke approvals for the use of antibiotics in livestock which violated FDA regulations.
These drugs are approved by the FDA for allergies, rhinitis, and urticaria.
Recently, risperidone was approved by the US FDA for the treatment of irritability in children and adolescents with autism.
* Iloperidone ( Fanapt )-Approved by the FDA on 6 May 2009.
The paramount objectives driving policy decisions by the FDA are safety and efficacy of healthcare products.
In the U. S., the FDA has banned import of any donor sperm, motivated by a risk of Creutzfeldt – Jakob disease, inhibiting the once popular import of, for example, Scandinavian sperm.
The FDA informed health care professionals that dangerous or even fatal skin reactions ( Stevens – Johnson syndrome and toxic epidermal necrolysis ), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen ( HLA ) allele, HLA-B * 1502.
The Chagas Biovigilance Network reports current incidents of Chagas-positive blood products in the United States, as reported by labs using the screening test approved by the FDA in 2007.
Protein-bound paclitaxel ( e. g., Abraxane ) or nab-paclitaxel was approved by the U. S. Food and Drug Administration ( FDA ) in January 2005 for the treatment of refractory breast cancer.
As a result of FDA enforcement action, by August 2010, 88 % of the hydrocodone-containing medications had been removed from the market.
In consequence, the United States Department of Agriculture ( USDA ) has approved the use of low-level irradiation as an alternative treatment to pesticides for fruits and vegetables that are considered hosts to a number of insect pests, including fruit flies and seed weevils ; the U. S. Food and Drug Administration ( FDA ) has cleared among a number of other applications the treatment of hamburger patties to eliminate the residual risk of a contamination by a virulent E. coli.
These doses are above those currently permitted for these food items by the FDA and other regulators around the world.
* Remarks by Mark Worth, Public Citizen, to the FDA, Jan. 12, 2005
* Lithium – Lithium is the " classic " mood stabilizer, the first to be approved by the US FDA, and still popular in treatment.
It is approved by the United States ' Food and Drug Administration ( FDA ) for the treatment of narcolepsy, shift work sleep disorder and excessive daytime sleepiness associated with obstructive sleep apnea.

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