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Manufacturing Supplement Reviews Will Not Lag Under PDUFA, FDA Says

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Executive Summary

Manufacturing supplement resubmissions will not suffer from a lack of review goals under PDUFA, Center for Biologics Evaluation & Research Associate Director for Review Management Robert Yetter, PhD, maintained during the Biotechnology Industry Organization annual meeting June 12

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Aventis To Increase Fluzone Supply As Wyeth’s FluShield Exits Market

Aventis-Pasteur is in discussions with FDA and the Centers for Disease Control & Prevention on ways to increase the supply of its influenza vaccine Fluzone following Wyeth's decision to discontinue FluShield

Aventis To Increase Fluzone Supply As Wyeth’s FluShield Exits Market

Aventis-Pasteur is in discussions with FDA and the Centers for Disease Control & Prevention on ways to increase the supply of its influenza vaccine Fluzone following Wyeth's decision to discontinue FluShield

Wyeth Will Lose 18.5% Of Marietta Sales If Firm Does Not Comply With GMPs

Wyeth-Ayerst would have to pay the government 18.5% of future net sales from products manufactured at its Marietta, Penn. facility if it fails to meet a timeline for bringing the plant into compliance with current Good Manufacturing Practices under an Oct. 3 consent decree with FDA.
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