(a) This part sets forth procedures and requirements for the submission to, and the review by, the Food and Drug Administration of applications and abbreviated applications to market a new drug under section 505 of the Federal Food, Drug, and Cosmetic Act, as well as amendments, supplements, and postmarketing reports to them.
(b) This part does not apply to drug products subject to licensing by FDA under the Public Health Service Act (58 Stat. 632 as amended (42 U.S.C. 201 et seq.)) and subchapter F of chapter I of title 21 of the Code of Federal Regulations.
(c) The following provisions do not apply to designated medical gases, which are subject to the certification and postmarketing reporting requirements under part 230 of this chapter:
(1) Sections 314.50 through 314.72;
(2) Section 314.80;
(3) Section 314.81, except paragraph (b)(3);
(4) Section 314.90;
(5) Subpart C of this part;
(6) Sections 314.100 through 314.162;
(7) Subpart H of this part; and
(8) Subpart I of this part.
(d) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[50 FR 7493, Feb. 22, 1985, as amended at 57 FR 17981, Apr. 28, 1992; 64 FR 401, Jan. 5, 1999; 89 FR 51782, June 18, 2024]
Notes of Decisions
In re Accutane Litig., 194 A.3d 503 (N.J. 2018).
“2 ; see generally , **267 21 C.F.R. § 314.1 to .170. As part of the NDA, the FDA requires extensive information, including the ingredients of the drug, its biological mechanisms, and the results of animal studies and clinical tests.”
Marcus v. Forest Pharm., Inc., 779 F.3d 34 (1st Cir. 2015).
“See 21 C.F.R. § 314.1 et seq. NDAs and sNDAs are subject to the same approval requirements.”
United States v. X-Otag Plus Tablets, 441 F. Supp. 105 (D. Colo. 1977).
· cites it 2× “21 C.F.R. § 314.1 (a). When the FDA approves the use of an ANDA, the manufacturer must comply with the provisions of 21 C.”
Pascale v. G. D. Searle & Co., 90 F.R.D. 55 (D.R.I. 1981).
· cites it 2× “See 21 C.F.R. § 314.1 et seq. The motion to modify was denied on July 31, 1980.”
Upjohn Mfg. Co. v. Schweiker, 520 F. Supp. 58 (W.D. Mich. 1981).
· cites it 5× “§ 355 (d); 21 C.F.R. § 314.1 (c)(12). Pursuant to FDA regulations, an NDA “may be refused” if it does not contain scientific investigations “on the basis of which it could fairly and responsibly be concluded .”
Hoffmann-La Roche, Inc. v. Harris, 484 F. Supp. 58 (D.D.C. 1979).
· cites it 2× “With respect to new drugs not previously marketed, FDA has almost universally required the pioneer applicant to support its application with detailed clinical reports of safety and effectiveness studies verified, or verifiable, by “raw data” as described in 21 C.F.R. § 314.1…”
Pharmadyne Labs., Inc. v. Kennedy, 466 F. Supp. 100 (D.N.J. 1979).
· cites it 2× “Following Hoffman-LaRoche, the FDA, without approving Lannett’s pending Abbreviated New Drug Applications (ANDAs), 21 C.F.R. § 314.1 (a), (b), 4 sought to condemn Lan *102 nett’s drugs.”
Chevron Chem. Co. v. Douglas M. Costle, 641 F.2d 104 (3rd Cir. 1981).
“§ 136h(d) (1978) now authorizes EPA disclosure in certain instances, and to that extent pro tanto limits the applicability of 18 U.”
The Upjohn Mfg. Co. & the Upjohn Co. v. Richard S. Schweiker, Sec'y, 681 F.2d 480 (6th Cir. 1982).
“§ 355 (d); 21 C.F.R. § 314.1 . During the two and one-half years which elapsed between the submission of the Boots application and approval by FDA of that application, FDA gathered considerable evidence with respect to the safety and effectiveness of ibuprofen.”
— 21 C.F.R. § 314.1(f) — 1 case
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