§1107.44. FDA action on an SE Report. — Inbound Citations

(c) An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22.

(a) FDA intends to review the SE Report and either communicate with the applicant as described in § 1107.40 or take an action under § 1107.44 within 90 calendar days of FDA's receipt of the SE Report, or within 90 calendar days of determining that the predicate was found to be commercially marketed (other than for test marketing) in the United States as of February 15, 2007 (if applicable), whichever is later. This 90-day period is called the “initial review cycle.”