PINL:GRPOF - Post by User
Post by
Pumper4Lifeon Oct 11, 2018 8:10am
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Post# 28779220
FDA type-C meeting
FDA type-C meetingQuite impressive, FDA will refuse TYPE A and C meetings if the product is not up to par. And Tetra has completed even Type C meeting.
Heres some interesting reading material on Type A-B-C meetings. Doesn’t look like an easy process, unless you know what you’re doing.
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf