Waiver of Informed Consent
FDA may authorize (21 CFR 50.23 (a) access for an individual patient without written consent if you and a physician not involved in clinical investigation of the drug you are applying for certify in writing that:
• The patient is in a life-threatening situation.
• The physician cannot communicate with the patient.
• Time is not sufficient to obtain consent from the patient’s legally authorized representative.
• No alternative method of approved or generally recognized therapy is available that provides equal or greater likelihood of saving the patient’s life.
If immediate use of a drug is needed to preserve the patient’s life, and there is no time to obtain a determination from a second physician that the conditions described above are met, you as the treating physician may administer the treatment. You must have the written determination reviewed and signed by an independent physician within 5 working days after emergency use of the drug.