Deleted
Deleted Member
Posts: 0
|
Post by Deleted on Dec 25, 2015 20:19:29 GMT -5
Does anyone know the status of Sanofi's insulin intended to be used with Afrezza? Are human trials required?
|
|
|
|
Post by esstan2001 on Dec 25, 2015 20:44:19 GMT -5
bioequivalence and batch consistency tests run, then a report submission to FDA, probable site inspection by FDA to ensure GMP compliance, that usually will suffice unless there is something that raises question.
|
|
|
|
Post by rvc on Dec 25, 2015 20:53:47 GMT -5
How do you know that it is intended to be used with Afrezza? Is this just conjecture?
|
|
