(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 Sec. 312.2(a).
(b) A sponsor shall not begin a clinical investigation subject to Sec. 312.2(a) until the investigation is subject to an IND which is in effect in accordance with Sec. 312.40.
(c) A sponsor shall submit a separate IND for any clinical investigation involving an exception from informed consent under Sec. 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]