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Vaccine Manufacturer Reaches Milestone In Licensing Process With FDA.(Brief Article)
2001 NOV 21 - (NewsRx.com & NewsRx.net) -- BioPort Corp. has reached a milestone in its licensing process with the U.S. Food and Drug Administration (FDA) by shipping required documentation for its manufacturing facility renovations to the FDA.
"We're entering what we hope will be the final stages of a long, rigorous technical process, and we're all proud we've reached this milestone," said Bob Kramer, president and chief operating officer of BioPort.
Kramer added that BioPort expects the FDA will request additional information and documentation during this phase of the submission. "It's entirely normal for the FDA to have additional questions after they review the material we've sent them."
"We're eager to move on from the hurdles we encountered during our plant renovation," Kramer said, adding that the company has "consistently labored against a ...
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