122. Emergency Use of an Investigational Drug for the Treatment of an Individual Patient by a Licensed Physician (§310)
A licensed physician under whose immediate direction an investigational drug is administered or dispensed for emergency use for an individual patient, is considered an investigator. She or he must comply with the responsibilities for investigators to the extent these apply to the emergency use.
- Clinicians must report adverse drug events to the sponsor.
- Clinicians must obtain informed consent as required.
- Clinicians must maintain accurate records including case history of patient and drug disposition.