21 CFR 312.40 - General requirements for use of an investigational new drug in a clinical investigation.
(1) The sponsor of the investigation submits an IND for the drug to FDA; the IND is in effect under paragraph (b) of this section; and the sponsor complies with all applicable requirements in this part and parts 50 and 56 with respect to the conduct of the clinical investigations; and
(b) An IND goes into effect:
(1) Thirty days after FDA receives the IND; or
(2) On earlier FDA authorization to ship the drug.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 312 after this date.