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Letter "J" » Jesse Goodman Quotes
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«It's premature to put a number on the actual supply for next year because manufacturing is continuing, and there are still some uncertainties with respect to Chiron, but we are very encouraged by being able to license this new vaccine, and also I think Chiron has reached a significant milestone in terms of their recent FDA inspection. We're encouraged by the positive track they're on, although the assessment is ongoing. The bottom line is it's encouraging. We certainly are hopeful that there will be additional vaccine beyond what was available last year.»
Author: Jesse Goodman
«The letter that we issued to them this week is a positive development and shows significant progress on their part. However, additional work is needed to determine the amount of vaccine Chiron may be able to supply the U.S. market for the upcoming flu season. FDA will evaluate the implementation and effectiveness of their corrective actions going forward. In addition, any vaccine produced must pass all tests for safety and potency before it can be marketed in the U.S.»
Author: Jesse Goodman
«We are pleased that the Chiron Corp. has taken steps to address issues at their facility in Liverpool as they prepare for the upcoming flu season,»
Author: Jesse Goodman
«That doesn't mean it's acceptable, but we need to keep the risk in perspective,»
Author: Jesse Goodman
«The simpler kinds of tests for antibodies won't work,»
Author: Jesse Goodman
«That's been an area of a lot of research, ... promising technologies.»
Author: Jesse Goodman
«Two weeks ago we issued an alert to blood banks»
Author: Jesse Goodman
«We are enthusiastic about the potential of having a very accurate, simple test in the home to increase testing and awareness in people about their HIV status. But we are seeking broad input from our panel and the public on the benefits and any risks.»
Author: Jesse Goodman
«It's a very, very important question.»
Author: Jesse Goodman
«This approval is the result of a tremendous cooperative effort among FDA, other public health agencies, the test kit manufacturers and the blood industry.»
Author: Jesse Goodman
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