BIOLOGICAL COOPERATIVE MANUFACTURING APPLICATIONS WILL BE REFUSED
Executive Summary
BIOLOGICAL COOPERATIVE MANUFACTURING APPLICATIONS WILL BE REFUSED by FDA if all parts of the application are not filed simultaneously, Center for Biologics Evaluation & Research Deputy Director Michael Beatrice said at the BioEast '94 convention in Washington, D.C. Jan. 25. Failure to submit all cooperative manufacturing applications for biologicals simultaneously is a "centerwide problem" because "we're under user fee time clocks and other mandated time frames that are part of the review process," Beatrice said.
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