A timeline of the FDA approval process and manufacturing of for a product possibly fentanyl. The timeline goes from 3/15/12 to 9/3/12. It includes items (in no particular order) such as: BE Study FDA Response; BE Study FDA Audit Results; Fentanyl 12 FDA Review Restart; FDA Approval; $60k printed and Long Lead Time Materials; Pouch Fabrication PV Lots; Stability Studies; and Launch. The timeline is color coded to indicate when a risk occurrence level is medium low or remote.
Description
Type
Category
-
Date
2009
Collection
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