(Total Views: 571)
Posted On: 10/15/2020 6:31:16 PM
Post# of 155647
Re: ClosetInvestor #61293
This is from JC_Greg, who wrote earlier today:
https://www.fda.gov/media/75398/download
Quote:
7.2.2. FDA Interaction with DMCs
In rare cases, we may wish to interact with a DMC of an ongoing trial to ensure that specific issues of urgent concern to FDA are fully considered by the DMC or to address questions to the DMC regarding the consistency of the safety data in the ongoing trial to that in the earlier trials, to optimize regulatory decision making.
https://www.fda.gov/media/75398/download
(3)
(0)
