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Atom0aks

08/15/19 9:28 AM

#209064 RE: invest2992 #209008

where will I find the rule book. can you provide a link I don't see it readily available on the website.



The link they provide on the "Formal Meetings with FDA" page doesn't work (https://www.accessdata.fda.gov/cder/sb-navigate/topic3/topic3/da_01_03_0030.htm) but it's the first link when you search their website for, "CDER 21st Century Review Desk Reference Guide" (https://www.fda.gov/media/78941/download). Chapter 4 describes the review process.