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MedImmune receives complete response letter from FDA for FluMist.(Brief Article)
2002 SEP 4 - (NewsRx.com & NewsRx.net) -- MedImmune, Inc., (MEDI) announced that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA) for FluMist (influenza virus vaccine live, intranasal), a live attenuated influenza vaccine delivered as a nasal mist.
FDA is requesting clarification and additional information relating to data previously submitted. No additional clinical trials have been requested.
"As expected, we received a complete response letter from the FDA requesting additional information relating to our FluMist application," said David M. Mott, MedImmune's ...
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