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Article: Need for Speed: FDA Pushes for Vaccine Approval Ahead of Data.
- Article from:
- BIOWORLD Today
- Article date:
- July 24, 2009
- Author:
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Byline: Donna Young, Washington Editor
GAITHERSBURG, Md. -- FDA advisers Thursday unanimously backed the agency's plan to approve a monovalent nonadjuvanted vaccine against the pandemic H1N1 2009 swine-origin influenza A virus under a strain change biologics license application supplement without waiting for data from required clinical trials.
The strain change supplement is the process the FDA currently uses each year when approving seasonal flu vaccines.
The FDA does not require seasonal flu vaccine makers to conduct new trials every year for their products. However, manufacturers must have their facilities inspected every year and must ...