Is use of drug, device or biologic with a single patient in an emergency situation within IRB purview?
A. If the drug, device or biologic is investigational, then the IRB must confirm the FDA criteria for emergency use are met. If the drug, device or biologic is: • Approved, and • Does not need an IND or IDE, and • Is being used off label or as marketed for clinical care, then the IRB does not need to confirm FDA criteria for emergency use are met. Please call ORI at 859-257-9428 if you have questions.
Related Questions
- Is use of drug, device or biologic with a single patient in an emergency situation within IRB purview?
- At END of Study - can the patient continue getting investigational drug –if it is beneficial to patient?
- Is the sight of the patient wearing the device more acceptable for him and his immediate family ?
