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US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain

 
• By Bridget Silverman

Ardelyx will add to FDA’s growing dispute resolution queue with plan to appeal tenapanor complete response letter; Avenue Therapeutics’ IV tramadol dispute resolution tops out with FDA plea for advisory committee advice.

Close up of girl's hand placing the last jigsaw puzzle piece with word Dispute Resolution
• Source: Shutterstock

Ardelyx Inc. is preparing to join the small group of sponsors challenging US FDA complete response letters through the formal dispute resolution process – a process that sees more appeals denied than accepted, but that nonetheless can offer valuable (if not always financially feasible) advice from the agency on how to address clinical evidence problems.

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