It's not good enough for a company just to have clinical trial data showing that its drug works; the Food and Drug Administration has to actually believe that the data is real.
Unfortunately for Johnson & Johnson
Site monitoring is a big deal. Independent doctors are usually on the front lines of clinical trials, and it’s the company's responsibility to make sure the doctors are following the procedural setup before the trial begins. Redoing a trial because of a screw-up could be a very costly process.
Fortunately for Johnson & Johnson, there's some precedence for this. Theravance
Lately, the FDA seems to be especially harsh on antibiotic drugs, and on Johnson & Johnson in particular. The agency turned down marketing applications for Johnson & Johnson's Doribax -- and an earlier ceftobiprole application -- as well as Wyeth's
Whether this is a permanent change in standards that might reduce future competition for current antibiotic makers like Cubist Pharmaceuticals
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