But the panel dashed the company's hopes, saying there wasn't enough long-term safety data.
The company will also have to submit new safety data emerging from ongoing trials.
Safety data incorporated into guidelines for adult care are also being taken into account.
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BNFL's faked safety data were not redundant, nor simply due to a few bored workers.
That remains his position, but it is now dependent on the results of a review of safety data.
Full safety data, including information on psychiatric and cardiovascular adverse events, will be presented at a later date.
And come up totally clean on the review of the rat safety data.
Schering-Plough is expected to present new safety data to address this on Tuesday.
Sincere thanks to all of the participants in the first-ever Safety Data Jam!
WHITEHOUSE: Safety Data Jam connects Tech Innovators with Public Safety Officers | The White House
Dr. Sharfstein supported me in my request to present my independent analysis of the Avandia safety data to the committee.
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The National Highway Traffic Safety Administration reviewed safety data, after Firestone claimed Ford's popular sports utility vehicle (SUV) was defective.
The makers have 30 days to provide safety data to support claims that the caffeine use is generally recognized as safe.
That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs.
This was the recommendation of the independent Data Monitoring Committee (DMC) based on its 5th unblinded review of all study safety data.
Operational integrity and safety data should be scrutinized to determine their accuracy.
The final safety data on the drug will be presented at ASCO, and Porges thinks they will determine whether doctors really use the drug.
In September, the Safety Data Initiative will host a Safety Datapalooza at which a cross-section of the most innovative safety applications submitted will be highlighted.
WHITEHOUSE: Administration Safety Data Initiative Challenges App Developers | The White House
The British Heart Foundation said much more safety data was needed.
In fact safety data from study 329 had already been submitted to the regulatory authorities and had been presented publicly before this document was written.
James Stein of the University of Wisconsin-Madison calls the cholesterol suppressor "the hottest drug on the horizon, " although he cautions that longer-term safety data are needed.
To help kick off the Safety Data Initiative, today we are announcing two app challenges that take advantage of more than 700 open government datasets now available on Safety.
WHITEHOUSE: Administration Safety Data Initiative Challenges App Developers | The White House
Certainly one would agree that the quantity and the quality of the safety data and the involvement of the FDA in the planning of the LibiGel safety study all are positive indications for LibiGel.
Patients were tried on the drug before the trial started, meaning those with obvious side effects were screened out, and Crestor was so effective the study was stopped ahead of schedule, limiting the safety data.
When he had a patient who was breast-feeding, she supported his conclusion that it would be safer if the woman took the antipsychotic Risperdal instead of Lilly's Zyprexa because Risperdal had more safety data on that point.
Merck spokesman Tony Plohoros says that Merck's statement at the analyst meeting referred to its plan to gather and combine heart-safety data from three other studies, whose primary aim was to show Vioxx could prevent or treat cancer.
Indeed, in America, the Tourette Syndrome Association felt it necessary to issue a statement warning of the paucity of long-term safety data, especially in children, and the potential interactions of nicotine with drugs given to treat the syndrome.
ECONOMIST: Great drug, shame about the delivery system | The
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Safety data for KYNAMRO are based on pooled results from four Phase 3, randomized, double-blind, placebo-controlled trials with a total of 390 patients of which 261 patients received weekly subcutaneous injections of 200 mg of KYNAMRO and 129 patients received placebo for a median treatment duration of 25 weeks.
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Last month, OSTP and the Department of Transportation co-hosted a Safety Data Jam at the Eisenhower Executive Office Building that brought together 40 leaders from technology, public safety, and government communities to discuss public safety challenges and to brainstorm creative new solutions that leverage open government safety data.
WHITEHOUSE: Safety Data Jam connects Tech Innovators with Public Safety Officers | The White House
But it will be at least a couple of years before enough safety data is collected in order to deem Tysabri effective enough to validate the risks of PML. Recent clinical studies of more than 3, 000 patients indicate the risk of contracting PML is roughly 1 in 1000, given the three confirmed cases.
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