Therapeutic medicine of diabetes " The changes of dynasties "

Therapeutic medicine of diabetes " The changes of dynasties "
Prepare against by the dispute lowering the intersection of candy and the intersection of medicine and document, guiding refined to use extensively no longer, the decision mark diabetic treatment " changes of dynasties " .
European Bureau of Drugs Supervision and the intersection of U.S.A. and FDA adopt, coordinate action, announce, prepare against by the dispute lowering the intersection of candy and the intersection of medicine and article, guiding too refinedly to use extensively again.
European Bureau of Drugs Supervision (EMA) Adopt and coordinate the action and announce unusually on September 23 to U.S.A. FDA, is guided too refinedly to use extensively again by the therapeutic medicine document of diabetes of the dispute.
The safe position of medicine is tough
The documents will be all stopped if the documents guides the refined sale in Europe, and the American patient is only after the doctor proves they have already tested all other medicines and got the practical heart risk to warn, could use the document to guide refinedly. Taking the document may continue being demanded to do it in this way to guide the refined patient.
The decision of FDA shows, even if face scientific uncertainty, Palestinian horse's authorities are adopting tougher position in the security of medicines. While FDA announced this restriction, this regulator puts up on its website and comes from the officer and in some cases proposes the memorandum inside what the complete contradiction is proposed for the first time. FDA chief Margaret? Dr. Hamburg says, in guiding refined decision in document, runs high inside this regulator warmly.
The cardiology family history Tiffin from Creveling clinic? Nissen's research once made the document guide the refined heart disease risk and is paid attention to, Nissen say the decision make " the the intersection of we and one's remaining years abominable safe incident of medicines most one of " Dying, he adds, " what mistakes appear in the procedure on earth it is necessary to investigate and supervise in an all-round way, in order to prevent this kind of tragedy from endangering a patient in future. "
One research estimate, from 1999 to 2009, have up to 47,000 take document, guide refined patient take place heart disease, apoplexy, in heart failure or death while being unnecessary.
New era of diabetic treatment
This guides the refined decision to the document, mark diabetic a new era for treatment, diabetes is reaching the prevailing proportion in a lot of industrialized countries.
Guide the refined reason because of the document, announce FDA at 2008,this of regulator will only because can control blood glucose levels diabetic not to be sanctioned these medicineses' listing some medicines. This standard has gone on for more than 80 years. Instead, FDA insists on now, the clinical trial in two years that the pharmaceutical manufacturer should last at least, in order to indicate their medicines will not do harm to heart, and these medicines can improve diabetic's life quality or lengthen patient's life-span, have increased and tested the difficulty greatly.
FDA compels and restrains the document from guiding the refined decision sold and revealing too, given in a law in 2007 to FDA of new power which pharmaceutical manufacturer and medicines distribute to intend to utilize the power. This organization has already compelled several dozen kinds of medicines to be sold under the special limiting condition.
, FDA medicine is assessed and research center (CDER) Director Janet? Dr. Woodcock says: "We know medicines prove that is not read frequently. " This is unusual recognition of reputable personage from this regulator, FDA has nearly relied on explaining and warning simply that control the use of medicines in these decades.
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