C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 312—INVESTIGATIONAL NEW DRUG APPLICATION › Subpart A—General Provisions

21 C.F.R. § 312.1

Scope

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(a) This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of that drug.

(b) References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

Notes of Decisions
Cited in 19 cases, 1978–2020 · leading case: Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
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Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). · cites it 2× “§ 355 (i); 21 CFR § 312.1 et seq. (2007). Clinical trials generally proceed in three phases involving successively larger groups of patients: 20 to 80 subjects in phase I; no more than several hundred subjects in phase II; and several hundred to several thousand subjects in…”
United States v. Ronald C. Smith, M.D., Robert Miltimore & Donald F. Mitchell, 740 F.2d 734 (9th Cir. 1984). · cites it 4× “§§ 355 (i) and 331(e) in conjunction with 21 C.F.R. § 312.1 make it a crime for a clinical investigator to maintain inadequate or inaccurate records.”
Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005). “§355 (i); 21 CFR §312.1 et seq. (2005). 2 The IND must describe “preclinical tests (including tests on animals) of [the] drug adequate to justify the proposed clinical testing.”
United States v. An Article of Food, Etc., Foodscience Labs., Inc., Claimant-Defendant-Appellant, 678 F.2d 735 (7th Cir. 1982). · cites it 2× “355(i) and 21 CFR 312.1, has been accepted as adequate by the United States Food and Drug Administration.”
Asahi Kasei Pharma Corp. v. Actelion Ltd., 222 Cal. App. 4th 945 (Cal. Ct. App. 2013). “( 21 C.F.R. § 312.1 et seq. (2013).) An IND for Fasudil had been approved by the FDA.”
Peter H. Forsham v. Joseph A. Califano, Jr., Sec'y of the Dep't of Health, Educ. & Welfare, 587 F.2d 1128 (D.C. Cir. 1978). “21 C.F.R. § 312.1 (a)(12)(6)(e) gives the FDA the right of access to investigator’s records relating to investigational new drugs (INDs).”
White v. Weiner, 562 A.2d 378 (Pa. 1989). “§ 355 (b)(1)(A); see also 21 C.F.R. §§ 312.1 to 312.6. Additionally, after receiving approval, a manufacturer regularly must update its application with data or information, received or otherwise obtained by such applicant with respect to such drug, as the Secretary may by…”
Leo Winter Assocs., Inc. v. Dep't of Health & Human Servs., 497 F. Supp. 429 (D.D.C. 1980). · cites it 2× “§ 355 (i) requires that records be maintained by manufacturers or sponsors of new drugs consistent with 21 C.F.R. § 312.1 (a) and Part 314. Those regulations require, inter alia, that the sponsor (1) maintain adequate records showing the investigator to whom the drug is shipped,…”
United States v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979). “§ 355 (i) and 21 CFR 312.1, has been accepted as adequate by the Food and Drug Administration.”
Schiff v. Prados, 2001 Cal. Daily Op. Serv. 8547 (Cal. Ct. App. 2001). “…of the federal act ( 21 U.S.C. § 355 (i)), which permits the drug to be clinically tested in humans (§ 109325; see 21 C.F.R. § 312.1 et seq. (2001)); or (3) specified alternative conditions, including filings with the Medical Board of California, are fulfilled (§§ 109300,…”
Nutrilab, Inc. v. Schweiker, 547 F. Supp. 880 (N.D. Ill. 1982). · cites it 2× “355(i) and 21 C.F.R. 312.1, or (iii) the Food and Drug Administration has advised plaintiffs that the drug is not a “new drug”; (2) manufacturing, processing, packing, and labeling such articles of drug after shipment of one or more of their components in interstate commerce…”
United States v. Undetermined Quantities of Articles of Drug, 145 F. Supp. 2d 692 (D. Maryland 2001). “§ 356© and 21 C.F.R. § 312.1 , has been accepted as adequate by the Food and Drug Administration; (B) Introducing or delivering for introduction into interstate commerce any such article of drug so long as the article is misbranded within the meaning of 21 U.”
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