[JAN] Emergency Use Authorization (EUA) Flashcards
1
Q
When can it be allowed?
A
It is a ‘Rare Disease’
Massive disease outbreak
No proven vaccine or drug available
Evidence of a drug or vaccine that is tested in a country and has yielded desired results
A country neither has the financial resources nor the personnel to conduct solid clinical trials to a drug/vaccine that has undergone thorough clinical trials in another country
2
Q
under which provisions?
A
New Drugs and Clinical Trials, 2019 mentions an ‘accelerated approval process’, depending on the severity, urgency and lack of alternatives.
