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If At First You Don’t Succeed, Try Dispute Resolution

 
• By Sue Sutter

More companies are turning to CDER’s formal appeals process when presented with a review division’s regulatory decision or advice. Even though few appeals are granted in full, many sponsors get valuable clarity on a path forward; some appeals, like that for Amarin’s Vascepa SPA, are turned away at the door.

Amarin Corp. PLC’s unsuccessful bid to seek reinstatement of a special protocol assessment for a Vascepa study through FDA’s formal dispute resolution process follows a growing trend, as biopharma companies increasingly turn to this appellate route when a review division gives them advice or a regulatory decision with which they do not agree.

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