Sabril warrants close attention because it's a clear near-miss for the drug approval system, a case where a medicine with a clear benefit for desperate patients foundered.
Some doctors and FDA officials fear the nascent trend poses dangers to the drug-approval system.
For Ahuja, that means issuing the final approval to operate a system that the company has been pursuing for more than a decade.
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The FDA based its approval of the NovoTTF 100A System on results from a single international clinical study in 237 patients with recurrent GBM or with GBM that hadn't responded to traditional therapy.
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Many consider the Manchin-Toomey compromise the best hope for winning Senate approval to widen the background check system, designed to screen out the severely mentally ill, criminals and others from getting firearms.
The most compelling argument for the current system of design and approval, however, is the excellent safety record of the scheduled airlines as well as Business Aviation.
The FDA said today that it had granted approval to the HeartWare Ventricular Assist System for use in heart failure patients waiting for a transplant.
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Officials with the Alyeska Pipeline Service Company said Tuesday evening that they received regulatory approval to restart the Trans Alaska Pipeline System to avoid freezing temperatures from affecting the pipes.
The latter would require congressional approval, as would any expansion of the system.
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According to court documents, officials with the Department of Health and Human Services' inspector general's office installed software on Mr. Liang's work computer that collected screen shots showing how he accessed the tracking system to follow Viibryd matters, including a document recommending approval of the drug.
The students said they had the approval of the flight crew, who let them use the plane's public address system to tell other passengers about their intentions.
There is no question in my mind that the system of aircraft design, certification and approval for operation is safe.
These are figures with enormous powers - and the pressure to legitimise them through some kind of parliamentary approval system has been building for quite a while.
At launch, it will be available on Android tablets running the Honeycomb operating system or higher, but Morgan says the company plans to submit its iOS app to Apple for approval in the next few weeks.
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On April 28 Dendreon of Seattle notched Food and Drug Administration approval for Provenge, its cell therapy designed to train the immune system to fight prostate cancer.
But reform of this system requires not only approval by Congress but ratification by the provinces.
As part of the approval, the ministry said Google couldn't use its Android operating system to discriminate against manufacturers.
The FDA approved the Argus II Retinal Prosthesis System as a humanitarian use device, an approval pathway limited to those devices that treat or diagnose fewer than 4, 000 people in the United States each year.
Making Brazil's absurdly generous pensions system slightly less so by raising the retirement age will require congressional approval but officials working on it hope that by pushing the pain into the future there is a chance it will pass.
Moreover, approval was contingent on Orphan setting up a system that carefully controls who gets the drug.
Tim Ferris has obtained federal approval to spread his program for Medicare patients to two other hospitals in the Partners Healthcare System, in Boston (including my own).
But final approval for the 787 also was contingent on Boeing, among other things, designing an automatic system able to disconnect the batteries from the plane's electrical grid in case of unexpected problems.
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