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FDA use of Amendment 1
Forums: General Discussion
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David
on April 5, 2012
FDA use of Amendment 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
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