Pre-clearance

An applicant must submit specimens of promotional labeling and advertising at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement, accompanied by Form FDA-2253 and a copy of the product's current professional labeling, and for drug products being considered for accelerated approval all promotional materials intended for dissemination or publication within 120 days following approval must be submitted during the preapproval review period, with later materials submitted at least 30 days prior to intended initial dissemination.

申請者は、販促用ラベリング及び広告の見本を、当該ラベリングの初回配布時及び当該広告の初回掲載時に、Form FDA-2253 及び当該製品の最新の professional labeling を添えてFDAに提出しなければならず、迅速承認（accelerated approval）の対象として審査中の医薬品については、承認後120日以内に配布又は掲載を予定するすべての販促資材を承認前審査期間中に提出し、120日経過後の資材は初回配布又は初回掲載の予定日の30日前までに提出しなければならない。