(Total Views: 640)
Posted On: 05/08/2020 8:55:07 PM
Post# of 153880
Rolling BLA
“Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”
If I’m not wrong CYDY rolling BLA doesn’t need every sections to be completed.
Does this sound correct?
“Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA”
If I’m not wrong CYDY rolling BLA doesn’t need every sections to be completed.
Does this sound correct?
(2)
(0)
