US FDA Formal Dispute Resolution Guides Evolution Of Trials For CKD Complications, Pain
Executive Summary
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.
You may also be interested in...
Drug Rejection Hearings Are Having A Moment At US FDA
With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.