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Posted On: 07/10/2019 9:09:21 AM
Post# of 149086
Looking it up, the FDA can provide feedback but it does not have too.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326266/
Quote:
Rolling Review does not require FDA to begin its review before receiving a complete application nor does it alter the goal for action on the NDA or BLA.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4326266/
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