FDA use of Amendment 1

Pinnacle 21 General General Discussion
1

Melanie,

I was recently at a meeting with the FDA and the reviewer asked for Amendment 1. However, it may depend on the reviewer so it is always a good idea to make this part of the discussion with the FDA when you are submitting data to them.

David

2

Dear all,

I just wanted to know if the FDA is OK to receive data with amendment 1 now or if they are still based on SDTM 3.1.2 ?

Thanks for your help !

Melanie