C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart B—Applications

21 C.F.R. § 314.71

Procedures for submission of a supplement to an approved application

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(a) Only the applicant may submit a supplement to an application.

(b) All procedures and actions that apply to an application under § 314.50 also apply to supplements, except that the information required in the supplement is limited to that needed to support the change. A supplement is required to contain an archival copy and a review copy that include an application form and appropriate technical sections, samples, and labeling; except that a supplement for a change other than a change in labeling is required also to contain a field copy.

(c) All procedures and actions that apply to applications under this part, including actions by applicants and the Food and Drug Administration, also apply to supplements except as specified otherwise in this part.

[50 FR 7493, Feb. 22, 1985, as amended at 50 FR 21238, May 23, 1985; 58 FR 47352, Sept. 8, 1993; 67 FR 9586, Mar. 4, 2002; 73 FR 39609, July 10, 2008]
Notes of Decisions
Cited in 7 cases (1 in the last 5 years), 2009–2023 · leading case: T.H. v. Novartis Pharm. Corp., 407 P.3d 18 (Cal. 2017).
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T.H. v. Novartis Pharm. Corp., 407 P.3d 18 (Cal. 2017). · cites it 2× “( 21 C.F.R. §§ 314.71 (a), 314.72(a)(2).) The same considerations led this court to unanimously reject a duty of care in O'Neil .”
Tummino v. Torti, 603 F. Supp. 2d 519 (E.D.N.Y 2009). · cites it 2× “§§ 355 (c), (d); 21 C.F.R. § 314.71 . Nevertheless, only the drug sponsor can supplement its initial new drug- application.”
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “21 C.F.R. § 314.71 sets forth the procedures for submitting a supplement to an application.”
All. Hippocratic Med. v. FDA (5th Cir. 2023). “We also recognize that it’s somewhat of a strain to say that the 2016 Major REMS Changes and 2021 Petition Denial (and related changes) altered the regulatory landscape to such a degree that the prior rule is only now “worth challenging” when it otherwise might “not have been.”
Smith v. GE Healthcare Inc (W.D. La. 2019). “21 C.F.R. § 314.71 (a). GE Healthcare was the NDA applicant for Omniscan.”
Lewis v. GE Healthcare Inc (W.D. La. 2020). “21 C.F.R. § 314.71 (a). GE Healthcare was the NDA applicant for Omniscan.”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “and then 10 21 C.F.R. § 314.71 sets forth the procedures for submitting a supplement to an application.”
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