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(c) An applicant may not amend an SE Report after FDA has closed the SE Report under § 1107.44 or it has been withdrawn under § 1107.22.

(c) If the applicant's response to FDA's deficiency notification(s) does not provide the information FDA requested, or the applicant provides information but the SE Report is still deficient, FDA generally intends to issue an order denying market authorization under the criteria set forth in § 1107.48. At any time before FDA issues an order, an applicant may make a written request to withdraw an SE Report under § 1107.22.