Share
7,284 Posts.
lightbulb Created with Sketch. 447
clock Created with Sketch. 23/11/19
14:12
Share
Originally posted by jamarco
↑
Does anyone know how long the FDA has to review Mayne's response to questions that will be submitted by end this calendar year? Original review time from first submission of ANDA for Nuvaring was 8 months (as standard). I've tried to do some searching re the complete response letter Mayne received from the FDA and what the next turnaround period is. There are several different possibilities based on the class of the questions / additional data required by FDA and it looks like the next review period could be anywhere from 2-6-8 months. Any ideas? Did anyone ask at AGM? I am thinking it is likely 6 months, prepared for 8, but hoping like hell it's 2!
Expand
Very important question and issue.
(20min delay)