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Drug companies will have to set up independent committees to monitor the rates of heart attacks, strokes, and heart-related deaths and hospitalizations linked to drugs in development.
Finally, the companies will have to conduct certain statistical analyses of the results, with an upper limit on how much risk is acceptable for a new drug.
But one bottom-line measure will not change: Diabetes drugs still will be judged on how well they lower blood sugars.
The FDA already sent letters to drugmakers describing the changes, Parks said. Makers of some 100 to 150 medications under development were notified.
"It is safe to assume that if we are going to be requiring a longer duration of trials, that it will add some years, some time to the clinical development process," added Parks.
The FDA's stance on new drugs still leaves room for discretion in approving diabetes medications.
"The idea is not to create such a high barrier that you will stifle innovation in developing new drugs, but to make sure clinicians have the information they need," said Nissen. "This will raise the level of evidence available, and that is good for patients."
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FDA policy: http://tinyurl.com/3g6xx6
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