Dear all,
What is the general consensus [if any] regarding safety narratives for BLA/NDA?
- simply link CIOMS forms to a general table outlining events
- full safety narratives on all events meeting criteria
I've seen from pushback from the FDA wanting more information, rather than less, and have asked that clients write full narratives with more comprehensive criteria [eg all deaths]. This has been especially true with biologics [mAbs].
Thoughts?
Kindest regards-
Colleen