2010.01.08 – Quiz: Criteria for Emergency Use Authorizations (EUAs), Investigational New Drug Applications (INDs), Emergency Investigational New Drug Applications (EINDS), and FDA-Approved Prescription Products.

Which of the following is incorrect?
A. An Emergency Use Authorization (EUA) for a medical product has a term of 1 year, but it can be renewed, depending on the circumstances of the emergency.
B. Informed consent is needed under Emergency Investigational New Drug Applications (EIND) and Investigational New Drug Applications (IND), but not needed in EUAs and FDA-approved prescription products
C. For peramivir to be prescribed under EUA, there should be documentation in the medical record that the patient and caregivers have been given the "Peramivir Fact Sheet for Patients and Parents/Caregivers," informed of alternatives to receiving peramivir, and told that peramivir is an unapproved drug to be used only under the EUA.
D. Prescriber safety reporting is mandatory in EUAs, EIND, IND and FDA-approved prescription products