It is the first FDA-approved clinical trial to inject fetal stem cells directly into the spinal cord of an adult.
They are agreements between a company and the FDA that a clinical trial, if conducted as planned and successful, should produce enough data for a drug to be approved.
On Monday, the FDA turned a halted clinical trial into a very scary warning about Aleve (see: " FDA Statement On Naproxen").
These are agreements between a company and the FDA about exactly what a clinical trial should show, and they give the company certain rights to appeal FDA decisions.
The FDA analysis of posted clinical trial data from May 2012 appears to contradict the BMJ study.
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Geron's treatment for spinal cord injury was the first human embryonic stem cell therapy to receive FDA approval for a clinical trial.
Supplies could become available to public health authorities in four to six months, and the FDA is reviewing the final clinical trial design, she said.
That could mean the results are close, but Novartis will have to wait until the trial is finished to file with the FDA. Another expected interim analysis from a second clinical trial will not be made public as was previously planned.
The FDA approval comes without a controlled clinical trial, which is usually required for a regulatory OK. But in studies, Velcade clearly helped a third of multiple myeloma patients who had failed two or more previous therapies--a stunning result in such a lethal disease.
They are to be commended, however, for blazing a trail that others can follow in getting the first clinical trial approved by the FDA, as such approvals should be easier in the future.
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The FDA recently gave Athersys permission to begin a clinical trial of MultiStem in patients 48 to 60 hours after a stroke has occurred.
The FDA approval for KYNAMRO is supported by the largest clinical trial conducted to-date in the HoFH patient population.
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Soon-Shiong said he would get Abraxane approved via an FDA rule that would let him use just one clinical trial.
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After a successful clinical trial, it received approval from the FDA in August.
There are many cases where all clinical trial results are not submitted to the FDA, and this is very well illustrated in, for example, the ongoing 2012 scandal over Tamiflu (discussed at length in my book, which LaMattina has not read).
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While the FDA does frequently give guidance as to what it seeks from clinical trial packages, this guidance can be further fleshed out by learning of its rationale for approving or rejecting certain drugs.
An initial late-stage clinical trial involving hundreds of patients is already under way, but the FDA will require a second set of tests.
The best minds fighting myeloma worked into the night in the Hilton ballroom and designed the clinical trial that got Velcade, a life-extending treatment, approved by the FDA in 2003.
It also meant that when the FDA finally did approve Provenge in 2010, it did so without a public meeting vetting that big clinical trial.
The clinical trial, which started to enroll patients in January 2011, is being conducted under an FDA-approved special protocol assessment, says Galena President and CEO Mark Ahn.
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