The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions.
* The average nurse spends eight hours per week online for professional purposes, which is just as much time as physicians, and almost all of them use the Internet in between patient consultations.
Clinical trials are studies of drugs and biologics that are still in development and have not yet been approved by the FDA.
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With the introduction of tacrolimus, Sandoz is expanding patient access to cost-saving transplant treatment options in the US.
Slightly more patients discontinued the trial in the roflumilast group than those taking placebo (14 percent vs 11 percent).
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Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.
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Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm.
Blunts industry incentives to perform studies required for FDA label changes.
Except for the historical information contained herein, this release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
"However, it is not just about the H5N1 strain. Any further spread of the H1N1 virus between birds, or from birds to humans would not be good," Butter said.
Prescription drugs were approved by the Food and Drug Administration.
This study will evaluate the safety and effectiveness of an investigational drug called darapladib in preventing coronary artery plaque from rupturing.
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