Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&mc=true&r=SUBPART&n=sp21.5.312.a
Timestamp: 2020-08-06 02:00:12
Document Index: 257543144

Matched Legal Cases: ['art 312', '§312', '§312', '§312', '§312', '§320', 'art 314', '§56', 'art 56', '§201', '§312', '§312', '§312']

Title 21 → Chapter I → Subchapter D → Part 312 → Subpart A
§312.1 Scope.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)).
(v) The investigation is conducted in compliance with the requirements of §312.7.
(2)(i) A clinical investigation involving an in vitro diagnostic biological product listed in paragraph (b)(2)(ii) of this section is exempt from the requirements of this part if (a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure and (b) it is shipped in compliance with §312.160.
(3) A drug intended solely for tests in vitro or in laboratory research animals is exempt from the requirements of this part if shipped in accordance with §312.160.
(c) Bioavailability studies. The applicability of this part to in vivo bioavailability studies in humans is subject to the provisions of §320.31.
(d) Unlabeled indication. This part does not apply to the use in the practice of medicine for an unlabeled indication of a new drug product approved under part 314 or of a licensed biological product.
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.
(c) The appropriate FDA Center Director, according to the procedures set forth in §§201.26 or 610.68 of this chapter, may grant an exception or alternative to the provision in paragraph (a) of this section, to the extent that this provision is not explicitly required by statute, for specified lots, batches, or other units of a human drug product that is or will be included in the Strategic National Stockpile.
(b) Charging in a clinical trial—(1) Charging for a sponsor's drug. A sponsor who wishes to charge for its investigational drug, including investigational use of its approved drug, must:
(2) For expanded access under §312.320 (treatment IND or treatment protocol), such assurance must include:
(iii) Information submitted under the general investigational plan (§312.23(a)(3)(iv)) specifying the drug development milestones the sponsor plans to meet in the next year.
(2) For expanded access to an investigational drug for treatment use under §§312.315 (intermediate-size patient populations) and 312.320 (treatment IND or treatment protocol), in addition to the direct costs described in paragraph (d)(1)(i) of this section, a sponsor may recover the costs of monitoring the expanded access IND or protocol, complying with IND reporting requirements, and other administrative costs directly associated with the expanded access IND.
[52 FR 8831, Mar. 19, 1987, as amended at 52 FR 23031, June 17, 1987; 67 FR 9585, Mar. 4, 2002]