?? They have to have a pandemic exemption for paperwork issues??
FDA regulations describe the circumstances under which CDER may refuse to file an application. For NDAs, §§ 314.101(d)(1), (2), and (4)–(9) provide many of the reasons for taking an RTF action; CDER considers these reasons to apply to BLAs as well (with
6
The ? The NDA does not contain a completed application form (§ 314.101(d)(1))
the exception of § 314.101(d)(9), which applies only to 505(b)(2) applications). reasons are listed below and do not require more detailed explanation:7
? The NDA is not submitted in the form required under § 314.50 (§ 314.101(d)(2)) (see Attachment 2, section 1)
? The applicant fails to submit a complete environmental assessment, which addresses each of the items specified in the applicable format under 21 CFR 25.40 or fails to provide sufficient information to establish a categorical exclusion under 21 CFR 25.30 or 21 CFR 25.31 (§ 314.101(d)(4))
? The NDA does not contain accurate and complete English translation of each part of the NDA that is not in English (§ 314.101(d)(5))
? The NDA does not contain a statement for each nonclinical laboratory study that the study was conducted in compliance with the requirements set forth in 21 CFR part 58 or, for each study not conducted in compliance with part 58, a brief statement of the reason for the noncompliance (§ 314.101(d)(6))
? The NDA does not contain a statement for each clinical study that the study was conducted in compliance with the institutional review board regulations in 21 CFR part 56, or was not subject to those regulations, and that it was conducted in compliance with the informed consent regulations in part 50, or if the study was subject to but was not conducted in compliance with those regulations, the NDA does not contain a brief statement of the reason for the noncompliance (§ 314.101(d)(7))
? The drug product that is the subject of the submission is already covered by an approved NDA and the applicant of the submission: (1) has an approved NDA for the same drug product; or (2) is merely a distributor and/or repackager of the already approved drug product (§ 314.101(d)(8))
6 See note 1, supra.
7 The reasons listed reflect the regulatory text pertaining to NDAs only.
