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Nasal spray flu vaccine developed at U-M needs no additional clinical trials, says FDA.(Brief Article)
2002 AUG 7 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration has asked for additional information, but no additional clinical trials, as it considers approval of FluMist, an influenza vaccine delivered as a nasal spray.
FluMist was invented by Hunein "John" Maassab after more than 4 decades of research at the University of Michigan (U-M) School of Public Health. Gaithersburg, Maryland-based MedImmune has licensed the rights to FluMist from U-M, and has a marketing agreement with Wyeth.
"I am pleased that the FDA does not believe that additional clinical trials are necessary. The efficacy of FluMist is clearly established. I expect that MedImmune will be able to respond to any FDA questions. I am happy to see this progress," Maassab said July 11, 2002.
Maassab finished his doctoral dissertation on influenza in 1956, inspired by his mentor, Dr. Thomas Francis Jr., who had overseen the U.S. Army's flu vaccine program during World War II. Francis was ...
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