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If you are using or recommending this test, this might be of interest with the latest FDA action until it is determined if the the specifications meet the specifications as developed at Yale. BD The FDA has warned clinical-test giant LabCorp that it has been marketing an ovarian cancer test...
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Many of the generic manufacturers started years back with knock off drugs to sell locally in India, but now the game is changing to where US Pharma is using some of the talent, which costs less than R and D individuals here in the states, to further develop existing work, in other words somewhat continue...
Posted to
The Medical Quack .... by Barbara Duck
by
The Medical Quack
on
09-05-2008
Filed under:
Filed under: Medically Related, Pharma/FDA News, Genomics, drugs, Pharma, Biotech, Cancer, FDA, Budgets, R and D, Alzheimers, Outsourcing
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One cancer drug turned down after many years of research, but the company plans an appeal. The FDA continues to ask for substantial documentation in the hopes of better decision. Refusals don't help the cause when it comes to investors and the potential for continued research. Something...
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This is an interesting opinion story from an individual that has a natural health site, which many have been criticized over the years as over talking what natural herbs and cures can product as far as results. This particular individual states only 1% of his entire site was related to cancer and...
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This procedure is not approved for us in the US. It is not inexpensive either at 25-30K per procedure, but good money for the physicians getting paid from 5-7k for their work. There are opinions on both sides of the fence and like anything else today, there has not been one cure all that works...
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One change made by Labcorp is that OvaSure™ test cannot be used by a woman who has had both ovaries removed, ok now isn't this a given, why would a woman have this test who has no ovaries? The test is known as what is called a “home brew” test, which the FDA has not chosen in the past to regulate...
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This article brings up a good point, when a patient has no other choices and the potential of a new drug could offer some relief, what is the verdict at this point? The FDA has turned it's way of thinking around now to being much more conservative on the drugs that are approved. Do the drug companies...
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The patent is stated not to expire until 2010 and this will put a 30 hold at the FDA to grant approval. This one should prove interesting to follow and see where the infringement occurs. BD LONDON -(Dow Jones)- Sanofi-Aventis SA (SNY) has launched a legal action against Canadian generic drugmaker...
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American Society of Clinical Oncology and Blue Cross/Blue Shield of Michigan will collect cancer information from 11 oncology practices in Michigan. Each physician will be paid around $3000.00 for their time in for the collection process. This is good for the exchange of information...
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This is one tough subject by all means. Yes, consumers want early access, but on the other hand if there’s not enough information regarding issues such as side effects, a drug could in fact hasten the process with individuals dying sooner, again studies are what is needed to be safe. ...
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This inquiry revolves around the pediatric use of the drugs to investigate any relationship to the development of cancer. In a related story, another pharma company is working with the FDA on a safety study produced in Europe with adverse effect reported, so the approval in Europe with additional...
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Help to make sure the contractors for Medicare payments and physicians have the latest information on what will be compensated, which changes almost daily. The burden for payment is on the contractor to check for FDA approval, and then further to see if there is any scientific evidence that supports...
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Good insight and commentary here from the "inside" track...are members of Congress helping or stalling the progression of the FDA... will the Biotechs be able to develop and withstand some of the stringencies and additional methodologies to bring new products to market to save lives? Nice to...