The Food and Drug Administration aims to make a decision on any drug marketing application within 10 months -- six months, if the drug is given a priority review. Many drugmakers hear back on the exact day of the deadline, referred to as the PDUFA date.
In the big picture, a few days won't make a bit of difference. While antibiotics from Johnson & Johnson
What kind of label Dificid will get, on the other hand, is still a bit of a mystery. The committee of outside experts split six to six over whether the lack of recurrences of infections was clinically meaningful. Optimer and marketing partner Cubist Pharmaceuticals
Personally, I think the FDA should just put the data on the label and let individual physicians make up their mind whether it's important or not. But the agency tends to be a little high and mighty when it comes to thinking that it knows what's best for patients -- that is its job, I guess. Figuring out which way the agency will go is a little tough.
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