§ 312.36 - Emergency use of an investigational new drug (IND).

Need for an investigational drug may arise in an emergency situation that does not allow time for submission of an IND in accordance with § 312.23 or § 312.34. In such a case, FDA may authorize shipment of the drug for a specified use in advance of submission of an IND. A request for such authorization may be transmitted to FDA by telephone or other rapid communication means. For investigational biological drugs regulated by the Center for Biologics Evaluation and Research, the request should be directed to the Office of Communication, Training and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research, 301-827-2000. For all other investigational drugs, the request for authorization should be directed to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, 301-827-4570. After normal working hours, eastern standard time, the request should be directed to the FDA Office of Emergency Operations (HFA-615), 301-443-1240. Except in extraordinary circumstances, such authorization will be conditioned on the sponsor making an appropriate IND submission as soon as practicable after receiving the authorization.