Answer: The 120-day review period begins to run upon FDA's receipt of the FCN.
There is some difference of opinion as to what "receipt" means. For our purposes in fixing a date, we hand-deliver our FCNs to FDA, so we can get a stamped "received" acknowledgment from FDA. Were a dispute to arise regarding the timing issue, we think this would be read by a court of law as the "receipt" date contemplated by FDAMA.
On the other hand, it should be recognized that FDA has been taking the position that receipt of the FCN means the time it is delivered to the reviewing office. This will be a few days after the date the FCN is delivered to FDA due to security arrangements at the agency that create a delay between the initial delivery to FDA and actual arrival of the submission at the reviewer's desk. Ordinarily, this lapse of time is minimal so the difference of opinion can be considered inconsequential.
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