Source: https://www.law.cornell.edu/cfr/text/21/314.70
Timestamp: 2017-10-19 00:24:41
Document Index: 160657990

Matched Legal Cases: ['art 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 314', '§ 331', '§ 201']

21 CFR 314.70 - Supplements and other changes to an approved NDA. | US Law | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter D › Part 314 › Subpart B › Section 314.70
21 CFR 314.70 - Supplements and other changes to an approved NDA.
§ 314.70 Supplements and other changes to an approved NDA.
(a)Changes to an approved NDA. (1)(i) Except as provided in paragraph (a)(1)(ii) of this section, the applicant must notify FDA about each change in each condition established in an approved NDA beyond the variations already provided for in the NDA. The notice is required to describe the change fully. Depending on the type of change, the applicant must notify FDA about the change in a supplement under paragraph (b) or (c) of this section or by inclusion of the information in the annual report to the NDA under paragraph (d) of this section.
(b)Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes).
(1) A supplement must be submitted for any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product.
(c)Changes requiring supplement submission at least 30 days prior to distribution of the drug product made using the change (moderate changes).
(1) A supplement must be submitted for any change in the drug substance, drug product, production process, quality controls, equipment, or facilities that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. If the supplement provides for a labeling change under paragraph (c)(6)(iii) of this section, 12 copies of the final printed labeling must be included.
(d)Changes to be described in an annual report (minor changes).
(1) Changes in the drug substance, drug product, production process, quality controls, equipment, or facilities that have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the drug product as these factors may relate to the safety or effectiveness of the drug product must be documented by the applicant in the next annual report in accordance with § 314.81(b)(2).
(e)Protocols. An applicant may submit one or more protocols describing the specific tests and studies and acceptance criteria to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, and potency of the drug product as these factors may relate to the safety or effectiveness of the drug product. Any such protocols, if not included in the approved NDA, or changes to an approved protocol, must be submitted as a supplement requiring approval from FDA prior to distribution of a drug product produced with the manufacturing change. The supplement, if approved, may subsequently justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect.
(f)Patent information. The applicant must comply with the patent information requirements under section 505(c)(2) of the Federal Food, Drug, and Cosmetic Act and § 314.53.
(g)Claimed exclusivity. If an applicant claims exclusivity under § 314.108 upon approval of a supplement for change to its previously approved drug product, the applicant must include with its supplement the information required under § 314.50(j).
(h)Different drug. An applicant may not supplement a 505(b)(2) application to seek approval of a drug that is a different drug from the drug in the approved 505(b)(2) application. For purposes of this paragraph (h), a drug is a different drug if it has been modified to have a different active ingredient, different route of administration, different dosage form, or difference in excipients that requires either a separate clinical study to establish safety or effectiveness or, for topical products, that requires a separate in vivo demonstration of bioequivalence. However, notwithstanding the limitation described in this paragraph (h), an applicant may supplement the 505(b)(2) application to seek approval of a different strength.
[ 69 FR 18764, Apr. 8, 2004, as amended at 71 FR 3997, Jan. 24, 2006; 72 FR 73600, Dec. 28, 2007; 73 FR 49609, Aug. 22, 2008; 81 FR 69648, Oct. 6, 2016]
§ 331 to 374 - Omitted
21 CFR 201.26 — Exceptions or Alternatives to Labeling Requirements for Human Drug Products Held by the Strategic National Stockpile.
21 CFR 201.57 — Specific Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products Described in § 201.56(b)(1).
21 CFR 314.97 — Supplements and Other Changes to an Approved ANDA.
21 CFR 314.72 — Change in Ownership of an Application.
21 CFR 201.21 — Declaration of Presence of Phenylalanine as a Component of Aspartame in Over-The-Counter and Prescription Drugs for Human Use.
21 CFR 310.515 — Patient Package Inserts for Estrogens.
21 CFR 310.501 — Patient Package Inserts for Oral Contraceptives.
21 CFR 206.10 — Code Imprint Required.
21 CFR 314.53 — Submission of Patent Information.
21 CFR 201.56 — Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.
21 CFR 250.250 — Hexachlorophene, as a Component of Drug and Cosmetic Products.
21 CFR 211.132 — Tamper-Evident Packaging Requirements for Over-The-Counter (OTC) Human Drug Products.