Source: https://www.law.cornell.edu/cfr/text/21/314.125
Timestamp: 2018-06-24 05:45:22
Document Index: 629193792

Matched Legal Cases: ['art 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', 'art 320', '§ 314', 'art 207', 'art 58', 'art 56', 'art 50', '§ 320', '§ 320', '§ 312', '§ 312']

21 CFR 314.125 - Refusal to approve an NDA. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 314 › Subpart D › Section 314.125
21 CFR 314.125 - Refusal to approve an NDA.
§ 314.125 Refusal to approve an NDA.
(a) The Food and Drug Administration will refuse to approve the NDA and for a new drug give the applicant written notice of an opportunity for a hearing under § 314.200 on the question of whether there are grounds for denying approval of the NDA under section 505(d) of the Federal Food, Drug, and Cosmetic Act, if:
(1) FDA sends the applicant a complete response letter under § 314.110;
(2) The applicant requests an opportunity for hearing for a new drug on the question of whether the NDA is approvable; and
(b) FDA may refuse to approve an NDA for any of the following reasons, unless the requirement has been waived under § 314.90:
(2) The investigations required under section 505(b) of the Federal Food, Drug, and Cosmetic Act do not include adequate tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling.
(5) There is a lack of substantial evidence consisting of adequate and well-controlled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling.
(7) The NDA contains an untrue statement of a material fact.
(9) The NDA does not contain bioavailability or bioequivalence data required under part 320 of this chapter.
(10) A reason given in a letter refusing to file the NDA under § 314.101(d), if the deficiency is not corrected.
(11) The drug will be manufactured in whole or in part in an establishment that is not registered and not exempt from registration under section 510 of the Federal Food, Drug, and Cosmetic Act and part 207.
(12) The applicant does not permit a properly authorized officer or employee of the Department of Health and Human Services an adequate opportunity to inspect the facilities, controls, and any records relevant to the NDA.
(14) The NDA does not contain an explanation of the omission of a report of any investigation of the drug product sponsored by the applicant, or an explanation of the omission of other information about the drug pertinent to an evaluation of the NDA that is received or otherwise obtained by the applicant from any source.
(15) A nonclinical laboratory study that is described in the NDA and that is essential to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in its proposed labeling was not conducted in compliance with the good laboratory practice regulations in part 58 of this chapter and no reason for the noncompliance is provided or, if it is, the differences between the practices used in conducting the study and the good laboratory practice regulations do not support the validity of the study.
(16) Any clinical investigation involving human subjects described in the NDA, subject to the institutional review board regulations in part 56 of this chapter or informed consent regulations in part 50 of this chapter, was not conducted in compliance with those regulations such that the rights or safety of human subjects were not adequately protected.
(17) The applicant or contract research organization that conducted a bioavailability or bioequivalence study described in § 320.38 or § 320.63 of this chapter that is contained in the NDA refuses to permit an inspection of facilities or records relevant to the study by a properly authorized officer or employee of the Department of Health and Human Services or refuses to submit reserve samples of the drug products used in the study when requested by FDA.
(18) For a new drug, the NDA failed to contain the patent information required by section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act.
(19) The 505(b)(2) application failed to contain a patent certification or statement with respect to each listed patent for a drug product approved in an NDA that:
(i) Is pharmaceutically equivalent to the drug product for which the original 505(b)(2) application is submitted; and
(ii) Was approved before the original 505(b)(2) application was submitted.
(c) For drugs intended to treat life-threatening or severely-debilitating illnesses that are developed in accordance with §§ 312.80 through 312.88 of this chapter, the criteria contained in paragraphs (b) (3), (4), and (5) of this section shall be applied according to the considerations contained in § 312.84 of this chapter.
[ 50 FR 7493, Feb. 22, 1985, as amended at 53 FR 41524, Oct. 21, 1988; 57 FR 17991, Apr. 28, 1992; 58 FR 25926, Apr. 28, 1993; 64 FR 402, Jan. 5, 1999; 73 FR 39610, July 10, 2008; 74 FR 9766, Mar. 6, 2009; 81 FR 60221, Aug. 31, 2016; 81 FR 69658, Oct. 6, 2016]
21 CFR 314.90 — Waivers.