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Correspondence
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Volume 331:203-205 July 21, 1994 Number 3
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A Trial of RSV Immune Globulin in Infants and Young Children: The FDA's View

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 by Groothuis, J. R.
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To the Editor: We write regarding the article (Nov. 18 issue)1 reporting the results of a multicenter clinical trial that appeared to demonstrate the efficacy of immune globulin with a high titer of antibodies against respiratory syncytial virus (RSV immune globulin), given intravenously, in preventing RSV infection of the lower respiratory tract in high-risk children. The article was accompanied by a very positive editorial2. A scant two weeks later, the Blood Products Advisory Committee of the Food and Drug Administration (FDA) voted unanimously, on the basis of the same data, against recommending that this product be licensed. Although we . . . [Full Text of this Article]

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