Tag: accelerated approval

FDA, Regulations

FDA sets back Travere’s plans for kidney disease drug approval

May 26, 2021

Via: FierceBiotech

The FDA has crushed Travere Therapeutics’ hopes of seeking accelerated approval in a rare kidney disorder on the strength of existing interim data from a phase 3 clinical trial. Travere said it may have enough data to meet the FDA’s […]

FDA, News, Regulations

FDA commish finding his feet, COVID-19, and chaotic communication hitting speedy approvals

August 26, 2020

Via: FierceBiotech

The FDA’s accelerated approvals program is on shaky ground after a series of surprise rejections, poor communication and COVID-19-focused staff. This is according to analysis by an anonymous FDA consultant out of regulatory firm Prevision Policy, speaking to analysts at […]