Replies to post #12911 on FDA Plays

[DewDiligence]

It comes down to data gathered after the NDA submission. Is there an actual protocol for submitting this type of data? Give them a call and say, "Hey, we have some more data, we're sending it over?"

Yes, it’s common for applicants to submit additional data during an FDA review, but this can cause the PDUFA date to be extended.