What would the FDA do to expedite drug development and approval for an outbreak of smallpox,for which there is no known treatment?
A) List smallpox as a health orphan disease.
B) Omit the preclinical research phase.
C) Extend the clinical research phase.
D) Fast track the investigational drug.

Question

Quizplus · Accepted Answer

The best choice would be to fast track the investigational drug, which allows for expedited review and approval by the FDA. This process allows for quicker access to new drugs for patients with serious or life-threatening conditions, such as an outbreak of smallpox with no known treatment. Omitting the preclinical research phase or extending the clinical research phase could potentially delay the availability of a treatment. Listing smallpox as a health orphan disease may provide certain incentives for drug development, but may not necessarily expedite the approval process.

What Would the FDA Do to Expedite Drug Development and Approval