Relenza Cmte. Concerns Addressed In Labeling & Phase IV - FDA's Jolson
Executive Summary
Issues raised by an FDA advisory committee regarding Glaxo's Relenza have been adequately addressed in labeling and through Phase IV commitments, FDA Division of Antiviral Drug Products Director Heidi Jolson, MD, said in a memo explaining FDA's July 27 approval of the influenza treatment despite the committee's recommendation against approval.
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