Temple Wants US FDA To Consider Including PK/PD In Labels To Inform Dosing
CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject.
CDER's Robert Temple said the US FDA has generally been nervous about using PK/PD analyses to support labeling changes, but that it might be time to rethink the subject.