Word: fda
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Dates: during 2000-2009
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...During the debate, some generic companies went to Capitol Hill with a concern: BMS was asking the FDA to approve a new interpretation of the agency's rules that, if successful, would allow it to use the findings from its pediatric study - for which it already received six months of additional monopoly - to keep generic versions of the drug off the market for an extra 3 years. The reason? FDA regs entitle companies that change their labels due to new research to have an extra three years of exclusivity. BMS argued that since data gleaned from its pediatric study...
...CIPRO Despite public perception that Cipro is the ultimate-and only-treatment for anthrax, other antibiotics work equally well against the bacteria. Bayer, Cipro's maker, is simply the only company to conduct the additional testing (on animals) required to make the claim on its label. Last week the FDA fast-tracked approval for penicillin and doxycycline as well...
...WHAT ABOUT A VACCINE? Only one anthrax vaccine exists, made by one company, BioPort, for only one client: the U.S. military. But BioPort stopped producing the vaccine in 1998, when the FDA cited the company for lapses in quality control at its Lansing, Mich., plant. BioPort reapplied for approval last Monday, but in the interim, both the military and NIH have been pushing two newer vaccines into clinical trials, in hope of finding a vaccine with fewer side effects. Public health officials still see no need to inoculate the general public...
...Irradiation: Currently FDA-approved for use on meat, this process would kill off any dangerous bacteria by blasting mail with radioactive rays, much like...
...BioPort, the only manufacturer licensed by the FDA to make an anthrax vaccine, has stopped shipments because its facility did not meet FDA standards. BioPort began renovating its plant in 1999 and expects to begin filling orders again by the end of the year. The company's vaccine is available only to military and laboratory personnel and is not 100% effective. It can also have serious side effects. Without a real and present danger of a widespread anthrax attack, health experts believe it would be counterproductive to vaccinate the U.S. population...