CBER BIORESEARCH MONITORING INSPECTIONS FOR PLAs AND INDs REVEAL "NEGATIVE FINDINGS" TWO-THIRDS OF TIME; BIOLOGICS CLOSE TO CLEARING AWAY INACTIVE APPLICATIONS
FDA's Center for Biologics Evaluation & Research detects "negative findings" in two-thirds of its bioresearch monitoring inspections for PLAs and INDs, CBER Associate Director for Policy Rebecca Devine, PhD, said July 25 at a meeting of the Food & Drug Law Institute in Washington, D.C.
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