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 B—Investigational New Drug Application (IND)

21 C.F.R. § 312.20

Requirement for an IND

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(a) A sponsor shall submit an IND to FDA if the sponsor intends to conduct a clinical investigation with an investigational new drug that is subject to § 312.2(a).

(b) A sponsor shall not begin a clinical investigation subject to § 312.2(a) until the investigation is subject to an IND which is in effect in accordance with § 312.40.

(c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization from FDA. FDA shall provide a written determination 30 days after FDA receives the IND or earlier.

[52 FR 8831, Mar. 19, 1987, as amended at 61 FR 51529, Oct. 2, 1996; 62 FR 32479, June 16, 1997]
Notes of Decisions
Cited in 10 cases (2 in the last 5 years), 1985–2024 · leading case: Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017).
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Brennan v. Zafgen, Inc., 853 F.3d 606 (1st Cir. 2017). “; see also 21 C.F.R. § 312.20 . If the FDA approves that request, human testing begins.”
New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35 (1st Cir. 2008). “; see also 21 C.F.R. § 312.20 . If this request is approved, human testing begins, and typically follows three phases, commonly known as clinical trials.”
Miller v. Pfizer Inc.(Roerig Div.), 196 F. Supp. 2d 1095 (D. Kan. 2002). · cites it 2× “See 21 C.F.R. §§ 312.20 , 312.21. 17 . See 21 C.”
Mohr v. Targeted Genetics, Inc., 690 F. Supp. 2d 711 (C.D. Ill. 2010). · cites it 2× “See 21 C.F.R. § 312.20 . Before filing the IND, the applicant must have subjected biologically active agents of the proposed drug to comprehensive animal and human tissue testing.”
United States v. An Article of Device ... Diapulse, Etc., Appeal of Henry J. Niemeyer, M.D., 768 F.2d 826 (7th Cir. 1985). “1 (a)(12) and (13), forms FD-1572 and FD-1573 6g; 21 C.F.R. § 312.20 (Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects), 1.”
EUSA Pharma (US), Inc. v. Innocoll Pharm. Ltd., 594 F. Supp. 2d 570 (E.D. Pa. 2009). “21 C.F.R. § 312.20 (a). Second, an Investiga-tional Review Board must approve the trial after reviewing its protocol and past clinical trials on animals.”
Cowan v. United States, 5 F. Supp. 2d 1235 (N.D. Okla. 1998). “” 21 C.F.R. § 312.20 (b). In accordance with § 312.”
In Re Regulus Therapeutics Inc. Sec. Litig. (S.D. Cal. 2019). “14 See 21 C.F.R. §§ 312.20 , 312.40. Generally, an IND must contain, inter alia, “[a] 15 summary of the pharmacological and toxicological effects of the drug in animals, 16 and to the extent known, in humans.”
Karimian v. Alkermes Pub. Ltd. Co. (E.D.N.Y 2021). “21 C.F.R. § 312.20 . A clinical investigation is generally divided into three phases.”
An opinion was released in case 23-5200, Vanda Pharm., Inc. v. FDA (D.C. Cir. 2024). “§ 355(i)(1), 21 C.F.R. § 312.20 (a). The IND allows manufacturers to run clinical trials before obtaining marketing approval.”
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