21 C.F.R. § 312.20 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — DRUGS FOR HUMAN USE — INVESTIGATIONAL NEW DRUG APPLICATION — INVESTIGATIONAL NEW DRUG APPLICATION (IND) — Requirement for an IND

(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.

21 C.F.R. §312.20

52 FR 8831, 3/19/1987, as amended at 61 FR 51529, 10/2/1996; 62 FR 32479, 6/16/1997