Relenza Time-To-Alleviation Endpoint Not Perfect But Suitable - FDA's Jolson
Glaxo's prospectively defined endpoint in Relenza studies may be imperfect but is appropriate, FDA Division of Anti-Viral Drug Products Director Heidi Jolson, MD, counseled the agency's Antiviral Drugs Advisory Committee Feb. 24.
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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.
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011