Reply To: Grace period for label changes

Anonymous

Reply To: Grace period for label changes

May 29, 2024 at 11:41 pm

This has been very helpful, thank you for all the input. In parallel, we are changing the CRO for an ongoing OLE. What is the grace period for updating the CRO name and address on the label, specifically for Australia and Germany. In Germany, there is a period where we are under CTD and then transition to CTR around 2024.

#43692