Replies to post #202518 on Biotech Values

[Bickema]

is it safe to assume a 6 month PDUFA date for a resubmission?

EDIT: 2 Months or 6 Months depending on the classification of resubmission

The time frames for completing the review of Class 1 and Class 2
resubmissions were specified as 2 months and 6 months,
respectively, per 21 CFR 314.100; the time frame for issuing an
acknowledgment letter was changed from 14 days to 30 days;
language was added to clarify that a filing determination is not made
for resubmissions; minor editorial changes were made to make
clearer the process for determining whether a submission constitutes
a complete response that addresses all the deficiencies in the
complete response letter.