Filing Determination and Review Planning 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.
In addition to the filing determination, FDA also initiates review planning to work out timelines and review activities. This step helps ensure that the full review is timely and efficient. Following review planning, FDA will notify the Sponsor of any major review milestone timelines.
Full Review The full review extends from the filing decision to around Month 8 post-submission and to Month 5 for priority applications. During this phase, FDA performs a detailed review of the application. This generally involves consults between primary, secondary, and supervisory reviewers, reviewers from other disciplines, and other consultants from the various offices within FDA, as needed. Sponsors will likely receive additional information requests from FDA during the full review phase. The Sponsor should be prepared to respond to all such requests as completely and expeditiously as possible.
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