BIOLOGICAL COOPERATIVE MANUFACTURING APPLICATIONS WILL BE REFUSED
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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