"From the time a marketing application is submitted, FDA has 60 days to perform an initial review. During this time FDA will determine if the submission is sufficiently complete to perform a more substantive review. Day 60 post-submission is designated as the filing decision date.
Prior to the filing decision date, each review discipline will make a recommendation about the “file-ability” of the application.
If the initial review uncovers deficiencies, FDA may alert the sponsor at any time using information requests and/or may note the deficiencies as part of the filing letter. Refuse to file designations are made by Day 60 post-submission; otherwise, notification of filing review issues is provided to the sponsor by Day 74 in a communication commonly referred to as the 74-Day Letter. Sponsors should note that their turnaround time to address deficiencies in the 74-Day Letter is limited and that they should plan resourcing accordingly."
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