Dear Colleagues -
FDA just published the final ICH Q9 (R1) Guidance on QRM
https://www.fda.gov/media/167721/download
It includes some significant updates to the original QRM guidance from 2006.
I would be interested in everybody's thoughts on the changes and what that means for implementation.
Best,
Tina
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Tina Morris Ph.D.
Executive Director
AAPS
Arlington VA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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