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9 May 2012, 8:28 am
The suit had been brought by a group of death row inmates who alleged that they suffered a risk of severe pain during executions because the state uses nonmedical personnel to administer the lethal drugs in a manner not approved by the Food and Drug Administration or the drugs’ manufacturers. [read post]
8 May 2012, 5:03 pm
Under the Food, Drug and Cosmetic Act, a company in its application to the FDA must specify each intended use of a drug. [read post]
7 May 2012, 11:37 pm
Food and Drug Administration (FDA) to investigate a multistate outbreak of Salmonella Enteritidis infections which was associated with eating food from a Mexican-style fast food restaurant chain, Restaurant Chain A. [read post]
7 May 2012, 10:00 pm
Under the Food, Drug and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a drug. [read post]
7 May 2012, 2:59 am
The U.S. has resisted labeling, and in 1992 the Food and Drug Administration established a policy declaring there is no substantial or material difference between genetically engineered foods and foods that haven't been genetically engineered.Sleuthing for GMOs The question arises: How in the world do scientists determine if foods contain GMOs? [read post]
6 May 2012, 10:17 pm
The Food and Drug Administration (FDA), for example, denied a Natural Resources Defense Council (NRDC) petition on March 30, 2012 (after NRDC sued), as reported in the Food Liability Law Blog and the media. [read post]
5 May 2012, 6:37 am
In July 2011, the Food and Drug Administration (FDA) issued an update related to what it called ‘serious complications’ related to the use of vaginal mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). [read post]
4 May 2012, 10:00 am
Food and Drug Administration approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder. [read post]
4 May 2012, 4:30 am
A recent announcement by China’s State Food and Drug Administration outlines a potential policy shift, alluding to a proposed approval for the use of alternatives to animal testing for cosmetics. [read post]
4 May 2012, 2:59 am
But it's a slow and complicated process, and requires dialing back two years ago to when Food and Drug Administration Commissioner Margaret Hamburg told Congress her Office of Criminal Investigation (OCI) would begin using federal misdemeanor prosecutions to hold corporate officials responsible for food and drug safety.That announcement might have surprised some, but not FDA compliance attorneys, who knew the Department of Justice (DOJ) was working… [read post]
3 May 2012, 6:07 pm
The abbreviated new drug application for the generic is still pending approval from the Food and Drug Administration. [read post]
3 May 2012, 5:51 pm
Section 113 of the Food and Drug Administration Modernization Act of 1997 amended the PHS Act to add Section 402, which directs the Secretary of Health and Human Services (“DHHS”), acting through the Director of the National Institutes of Health (“NIH”), to establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (i.e., ClinicalTrials.gov). [read post]
3 May 2012, 10:31 am
In May 2011, the Food and Drug Administration (FDA) ordered twenty-one manufacturers of hip implant devices to collect and report data on metals levels in the blood of implant patients as well as the adverse health effects that may be caused by them. [read post]
3 May 2012, 5:00 am
Food and Drug Administration has specifically issued a “black box” warning that states that patients with dementia who take these antipsychotic drugs have an increased risk of death. [read post]
2 May 2012, 7:00 am
The US Food and Drug Administration has issued black-box warnings - the agency's most serious medication alert - about potentially fatal side effects when antipsychotics are taken by patients with dementia. [read post]
2 May 2012, 4:42 am
We are offering free case evaluations to the general public across the United States and Canada. [read post]
1 May 2012, 10:00 am
Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction. [read post]
1 May 2012, 5:56 am
Food & Drug Administration, and well-documented medical research from highly respected medical journals have all drawn attention to the potentially dangerous side effects associated with using Accutane. [read post]
30 Apr 2012, 4:37 pm
Employee background checks, drug testing of food stamp recipients, voter ID requirements—such practices enact what Lancaster calls the “preemptive paranoid approach” to governance. [read post]
30 Apr 2012, 11:19 am
A supplemental labeling regime for organic products: how the Food, Drug, and Cosmetic Act hampers a market solution to an organic transparency problem. [read post]
