Code of Federal Regulations Title 21. Food and Drugs § 21.312.40 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

(2) Each participating investigator conducts his or her investigation in compliance with the requirements of this part and parts 50 and 56.

(1) Thirty days after FDA receives the IND, unless FDA notifies the sponsor that the investigations described in the IND are subject to a clinical hold under § 312.42;  or

(2) On earlier notification by FDA that the clinical investigations in the IND may begin. FDA will notify the sponsor in writing of the date it receives the IND.

(1) Thirty days after FDA receives the IND;  or

(2) On earlier FDA authorization to ship the drug.