1. Briefly summarize how such an authorization can be obtained.
a) By submitting a formal application to the FDA
b) By obtaining approval from the CDC
c) By conducting a public referendum
d) By lobbying Congress for support
2. Contrast the differences between obtaining an Emergency Authorization and obtaining approval to use an investigational drug through expanded access or compassionate use.
a) Emergency Authorization requires FDA approval, while expanded access and compassionate use do not
b) Expanded access and compassionate use require FDA approval, while Emergency Authorization does not
c) Emergency Authorization allows immediate use in emergency situations, while expanded access and compassionate use are for non-emergency situations
d) There are no differences between the two processes
3. Do you think the risks of making investigational products available through Compassionate Use or Emergency Authorization is ethical in terms of what you have learned in this class and what are the risks and benefits to patients?
a) Yes, because it provides hope to patients with no other treatment options
b) No, because it bypasses the usual rigorous testing for safety and efficacy
c) Maybe, depending on the specific circumstances and risks involved
d) I'm unsure, more information is needed