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America's Only Manufacturer Seeks FDA Approval To Ship.(Brief Article)
2002 JAN 16 - (NewsRx.com & NewsRx.net) -- The nation's only manufacturer of an anthrax vaccine has expressed confidence it will soon win federal approval to distribute the vaccine.
The U.S. Food and Drug Administration, which spent the week of December 20, 2001, inspecting BioPort Corp.'s labs, said that the company had satisfactorily addressed most of the procedures it wanted to see fixed before allowing the company to ship the vaccine.
"We are very pleased with the results of this inspection,'' BioPort spokeswoman Kim Brennen Root said. The company already has corrected four of the seven problems cited by the FDA, she said.
BioPort has been under pressure to win federal approval to distribute the vaccine, which it has been manufacturing since 1998 but has been unable to ship since failing FDA inspections in 1999 and 2000. The FDA has never said that the vaccine itself is unsafe; its objections have to do with the manufacturing process.
The FDA said December 19 that BioPort wouldn't be fully licensed until an inspection of the company where the vaccine is placed into vials was satisfactorily completed early in January 2002. In the past, BioPort has supplied the vaccine only to its own employees and the Pentagon. About 500,000 of the 2.4 million troops the Pentagon wanted to inoculate have received the vaccine, but the military's ...
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Source: HighBeam Research, America's Only Manufacturer Seeks FDA Approval To Ship.(Brief Article)