Amsco predicts resolution of application integrity issues in 18-24 months.
This article was originally published in The Gray Sheet
Executive SummaryAMSCO PREMARKET DATA INTEGRITY ISSUES SHOULD BE RESOLVED IN 18-24 MONTHS, the firm says. FDA suspended its review of pending premarket submissions sponsored by Erie, Pennsylvania-based Amsco after notifying the firm in January that it was being placed under FDA's application integrity policy (AIP). FDA took the action because Amsco demonstrated a pattern of skewing clinical protocols to achieve desired results and omitting unfavorable data from premarket submissions, according to agency staffers.
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