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. § 312.3

Definitions and interpretations

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(a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:

(b) The following definitions of terms also apply to this part:

Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-902, 52 Stat. 1040 et seq., as amended (21 U.S.C. 301-392)).

Clinical investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

Contract research organization means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of materials to be submitted to the Food and Drug Administration.

FDA means the Food and Drug Administration.

IND means an investigational new drug application. For purposes of this part, “IND” is synonymous with “Notice of Claimed Investigational Exemption for a New Drug.”

Independent ethics committee (IEC) means a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection. An institutional review board (IRB), as defined in § 56.102(g) of this chapter and subject to the requirements of part 56 of this chapter, is one type of IEC.

Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms “investigational drug” and “investigational new drug” are deemed to be synonymous for purposes of this part.

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. “Subinvestigator” includes any other individual member of that team.

Marketing application means an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.

Subject means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.

[52 FR 8831, Mar. 19, 1987, as amended at 64 FR 401, Jan. 5, 1999; 64 FR 56449, Oct. 20, 1999; 73 FR 22815, Apr. 28, 2008]
Notes of Decisions
Cited in 9 cases, 1989–2011 · leading case: Cacchillo v. Insmed, Inc., 638 F.3d 401 (2d Cir. 2011).
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Cacchillo v. Insmed, Inc., 638 F.3d 401 (2d Cir. 2011). “See 21 C.F.R. §§ 312.3 (defining “sponsor” and “investigator”), 312.”
TMJ Implants, Inc. v. Aetna, Inc., 498 F.3d 1175 (10th Cir. 2007). “Rather, it is the following definition of investigational new drug: “a drug that has not been approved for general use by the Food and Drug Administration but is under investigation in clinical trials regarding its safety and efficacy first by clinical investigators and then by…”
In Re Elan Corp. Sec. Litig., 543 F. Supp. 2d 187 (S.D.N.Y. 2008). “21 C.F.R. § 312.3 . The sponsor then hires “investigators” to conduct the clinical investigation — it is under the investigators’ immediate direction that drugs are administered or dispensed to subjects.”
Abigail All. for Better Access to Developmental Drugs v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “" See 21 C.F.R. § 312.3 (b). . In some circumstances, a Phase IV review is conducted, which "delineale[s] additional information about the drug’s risks, benefits, and optimal use.”
United States v. Najarian, 915 F. Supp. 1460 (D. Minnesota 1996). “See, 21 C.F.R. § 312.3 (b). 21 . Given the fact that the terms “adverse experiences” and "serious adverse experiences,” and the requisites of “informed consent” are detailed in the FDA's Regulations, we find the Defendant’s vagueness argument particularly attenuated.”
Dahl v. Hem Pharm. Corp., 7 F.3d 1399 (9th Cir. 1993). “” 21 C.F.R. § 312.3 (b). The application, had it been granted, would have allowed the use of Ampligen “in the treatment of patients not in the clinical trials.”
Kernke v. the Menninger Clinic, Inc., 173 F. Supp. 2d 1117 (D. Kan. 2001). “” 21 C.F.R. § 312.3 (b) (2001). On the other hand, a sponsor-in this case Aventis-“does not actually conduct the investigation unless the sponsor is a sponsor-investigator.”
Abigail All. for Better Access v. Von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007). “[3] Section 355(n)(3) of Title 21, United States Code, provides: The Secretary shall make appointments to each panel .”
DeVito v. Hem, Inc., 705 F. Supp. 1076 (M.D. Penn. 1989). “See 21 C.F.R. § 312.3 (b) (1988). The clinical investigations were conducted at defendant Hah-nemann University's (Hahnemann) facilities.”
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