Some doctors and FDA officials fear the nascent trend poses dangers to the drug-approval system.
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.
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.
It was the largest number of pre-orders Apple has ever taken in a single day and was far higher than we anticipated, resulting in many order and approval system malfunctions.
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"We have an approval and reimbursement system that is expensive, risk-averse and basically hostile to start-ups, " said William A. Sahlman, a professor of business administration at Harvard Business School, and an investor in Rest Devices.
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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But reform of this system requires not only approval by Congress but ratification by the provinces.
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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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.
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.
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.
Moreover, approval was contingent on Orphan setting up a system that carefully controls who gets the drug.
The latter would require congressional approval, as would any expansion of the system.
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There is no question in my mind that the system of aircraft design, certification and approval for operation is safe.
There are just two new American reactors under construction, neither with full regulatory approval (a third, approved under an earlier system and then put on ice, is also under way).
In Virginia, GOP Gov. Bob McDonnell recently won approval for overhauling his state's highway maintenance system by raising diesel and retail sales taxes and creating a mechanism for a potential future gasoline tax hike.
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.
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.
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.
As part of the approval, the ministry said Google couldn't use its Android operating system to discriminate against manufacturers.
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.
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).
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.
An international GPS ground station may have to get export approval to buy a new screen for its Dell laptop, because it is part of a system that is controlled.
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.
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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