In the panel meeting two days ago, members discussed whether Vivus should conduct further studies before or after approval.
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He proposed starting with a smaller preapproval trial to rule out risk and then doing a second, larger study, after approval.
In retrospect, that timing was particularly remarkable for a drug that was produced with a revolutionary new technology, and that after approval would be available in pharmacies nationwide to millions of American diabetics.
But he vows to pursue sweeping changes in how the FDA monitors device performance after approval, creating a massive database to track all "adverse events" far faster than today's paperwork reporting process can.
Nissen then walked through a series of slides arguing diabetes drugs are approved with almost no long-term data in patients with heart disease--even though, after approval, heart patients get the drugs for a long time.
Mr Berlusconi was uncharacteristically silent both before and after the approval of the budget.
Shares in Shanghai Fosun Pharmaceutical closed down 1% at 9.28 yuan today after the approval.
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The Advisory Committee gave mixed views about whether this outcomes study should be done before or after FDA approval.
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For the first 12 months after its approval, the stent is likely to dominate the market, delivering strong sales.
It is typical for Wall Street to sell after an approval because the fast money has already been made.
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The loan to quarry owners Welsh Slate helped speed up the acquisition of the site, after planning approval was granted in December.
With inability to grow Provenge in absence of competition, the direction of the sales trajectory after Zytiga approval becomes even more doubtful.
Work on Jersey's new animal shelter headquarters in St Helier can begin soon, after planning approval was confirmed by the Royal Court.
This type of harm can only be detected through population-based surveillance after drug approval, when large numbers of people are being treated.
In the heady weeks after the approval of Velcade, Adams met with Infinity Chief Executive Steven Holtzman, who had known Adams for 14 years and worked with him briefly at Millennium.
After the approval was handed down by India's Foreign Investment Promotion Board, the economic affairs secretary said AirAsia would now have to get the necessary licences from the country's aviation regulators.
After SEC approval, the proposal would go to shareholders.
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We launched to a closed user group of approximately 70 participants in September 2010 and then, after our Approval-in-Principle from the Central Bank of Nigeria, to the general public in February 2011.
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The stimulus measure, approved by the Senate Friday after earlier approval by the House, extends the 26-week limit on unemployment benefits to 39 weeks -- longer in states with high unemployment rates.
"I think it's unfortunate we are here four years after device approval and many of these questions are unanswered, " says William Maisel, a cardiologist at Harvard Medical School and chairman of the FDA panel that analyzes circulatory system devices.
The CBI also said it was opposed to plans by the executive to launch a review on whether third parties, such as environment groups or local residents, should be able to appeal after planning approval is granted to companies by local councils.
This is what is happening in the state of Pennsylvania, as that state is abruptly and suddenly questioning the marriage between Verizon and MIC after only a year and a half after official approval was given to the deal from federal regulators.
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"I believe that if the public were to 'buy' (Qsymia) after FDA approval, it would run the risk of severe, even fatal, consequences from another diet lemon, " Dr. Michael Lauer writes in Annals of Internal Medicine, also noting that the drug led to a slight increase in heart rates.
In January, six months after giving conditional approval, the Energy Department notified Severstal that it would not fund the Dearborn project after all putting plans for a third line for even more advanced steels on hold.
The upper house cleared Mr Kuroda after he won approval from the lower house on Thursday.
The final names will be announced after their formal approval by the International Astronomical Union.
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Several Arena shareholders said they had also invested in Dendreon, whose stock soared after the FDA approval.
After the Serbian approval, the EU's executive Commission recommended on Monday that the bloc should start membership negotiations with Serbia.
Something similar happened with breast cancer: Avastin won the Food and Drug Administration's approval after studies suggested it delayed disease progression.
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