Filing Determination and Review PlanningFrom 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 filing.
If the 60 day is a calendar 60 days, it’s getting close to crunch time..
trial time, page-36
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