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Regulatory News

ODAC votes to recommend neuroblastoma drug for first-ever approval based on trial using external control arm

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The FDA Oncologic Drugs Advisory Committee Oct. 4 voted decisively to recommend the first-ever approval supported by a clinical trial that relied on an external control arm—using patient-level data extracted from another trial. 

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Byline
Jacquelyn Cobb
Associate Editor
Paul Goldberg
Editor & Publisher
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Byline
Jacquelyn Cobb
Associate Editor
Paul Goldberg
Editor & Publisher
Table of Contents

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