"We're very confident in the safety and efficacy of Arcoxia, " says Merck spokeswoman Christine Fanelle.
Therefore, they argue, relying on the original drugmaker's safety and efficacy testing data is unsafe.
Equally important, the safety and efficacy of the combination has yet to be tested in people.
The success of a new drug depends upon many things beyond basic safety and efficacy.
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Cost savings with substandard safety and efficacy is as damaging as taking no drug at all.
All MusclePharm merchandise is rigorously tested for safety and efficacy and new products are always being formulated.
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Patients are currently being recruited to the Hammersmith study so the treatment's safety and efficacy can be treated.
Medtronic disputes the way he arrived at these values and stands behind the safety and efficacy of Infuse.
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What they didn't bet on is a string of controversies about the safety and efficacy of their medicines.
Still others work on company-funded clinical trials, the main way that medicines are studied for safety and efficacy.
An FDA spokeswoman said the agency was careful in choosing panelists and reviewing drug safety and efficacy data.
Moreover, the bar for safety and efficacy keeps going up, meaning that new drug applications also get more complicated.
For many new drugs, the REMS, not the traditional review of safety and efficacy, may be the most important hurdle.
These drugs are typically tested for safety and efficacy in adults but are also widely prescribed to children and teen-agers.
But so far, the PDUFA fees are used only to review the safety and efficacy of drugs before they are approved.
But he said there could be no doubt over the safety and efficacy of the drug before it was publicly distributed.
It doesn't stop ticking while a drugmaker does a five-year study to compare the drug, in safety and efficacy, with the alternatives.
In a prepared statement, Bayer said that it remains committed to patient safety and to evaluating the safety and efficacy of Trasylol.
Lucentis studies are important because they raise questions about safety and efficacy.
Reason: The knockoff artists hadn't proved safety and efficacy for their medicine.
Scientists returned to the laboratory, hoping to develop better delivery vehicles and to improve both the safety and efficacy of the treatments.
In 1984, legislation he championed waived the requirement that all "regular" generic drugs had to be clinically tested for safety and efficacy.
Although medicines can be sold only after their safety and efficacy have been proved, dietary supplements, such as Niteworks, get a laissez-faire pass.
After studying the safety and efficacy of the low-dose pill, the ministry's Central Pharmaceutical Affairs Council agreed in February to approve oral contraceptives.
With any off-label use, there are concerns about safety and efficacy.
How are patients, doctors and the FDA balancing safety and efficacy?
More than 13, 000 patients have been enrolled in one study to test the drug's safety and efficacy for an application with the Food and Drug Administration.
The FDA may be learning not to sit on data too long, for fear of losing control of the public debate about the safety and efficacy of particular drugs.
Medical experts are in great demand to not only participate in determining the safety and efficacy of experimental medicines but also in shaping the medical guidelines for us all.
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