If any of you think this shows that the Accelerated Approval program is working, your nuts.
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Based on these studies alone, AstraZeneca asked the FDA for accelerated approval of Iressa on Dec. 28, 2001.
The FDA gave the drug accelerated approval, and Pfizer is conducting post-marketing clinical trials to further evaluate its clinical benefit.
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Economic activity is expected to receive a boost from accelerated approval of public infrastructure projects, the IMF said on Tuesday.
"As with other treatments approved under our accelerated approval process, further studies are necessary for clarifying Velcade's clinical benefits, " McClellan said.
Iressa was reviewed and approved under the FDA's accelerated approval program, which is designed to give people with life-threatening diseases earlier access to promising drugs.
Avastin was approved to treat breast cancer under a process called accelerated approval, which allows cancer drugs to reach patients faster, and over the objections of an FDA advisory committee.
However, in cases where lifesaving drugs are being proposed and there are no good alternatives, our current speed, while faster than others, may not be fast enough, meriting further improvements in accelerated approval.
The results in that small group could allow Celldex to design a future trial that could, on its own, lead to accelerated approval with the Food and Drug Administration for the drug, known as CDX-011 or glembatumumab vedotin.
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Ironically, a study by Tufts Center for the Study of Drug Development economist Joseph DiMasi and Duke University professor Henry Grabowski found that between 1990 and 2005, 47% of oncology drugs received accelerated approval compared with 13% for all other drug classes.
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But instead of acknowledging that all the data is positive, and Avastin still squarely meets the standards for Accelerated Approval, and waiting for the longer, larger OS trial it now says it wants, FDA did what it always does, simply forcing its decision (a bad one) by imposing its power to do so on the sponsor and patients.
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This has been accelerated by the fall in his popular approval, down from 58% in December to 35% last month, according to a recent poll.
An accelerated strategy for MDS and multiple myeloma might shave a year off the approval process, Barer says.
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