Supplemental Validation Submission deadline extended
This article was originally published in The Gray Sheet
Executive Summary
Reprocessors will have until Nov. 1 to file additional validation data, FDA announces. The agency explains that some reprocessors submitted "good, but inadequate" information, necessitating additional time to complete supplemental validation submission (SVS) reviews. FDA will post additional details regarding SVS reviews by Aug. 13. The agency last updated its reprocessor validation guidance in May (1"The Gray Sheet" May 31, 2004, In Brief)...