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Project (Tulip (Chronic study (Using model out of apply, FDA black model…
Project
Tulip
Shelf life
FDA black model registration
Using model out of apply
Biology compatibility
Short-term adoption
Long-term exempt
Chronic study
Using model out of apply
FDA black model registration
Rationale from
Puffin
Classification definition
Important: key for clinical strategy
MAH
May make the project easier but need support
Type test
Urgent : maybe Sep.
Atlas
Dossier collect
project team build up
Get former registration dossier
CER
Who & How
Do we have support for this CER?
Collect lots of literature and history data