www.fdanews.com/articles/108162-glaxosmithkline-cervarix-won-rsquo-t-need-additional-tests
GlaxoSmithKline: Cervarix Won’t Need Additional Tests
June 30, 2008
GSK said it doesn’t expect the U.S. Food and Drug Administration to require additional studies for its vaccine to prevent cervical cancer before it can gain approval. Responding to questions raised by the FDA, the drug company said studies to be completed later this year for its Cervarix vaccine are likely to be enough to strengthen its case.
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