Question No 8:
A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial that will form the primary basis of an efficacy claim in an NDA. Which of thefollowing is TRUE?
A. The sponsor should submit the SPA request within 30 days following the start of the trial to expedite FDA feedback
B. An SPA provides an opportunity to focus on general drug development issues
C. The SPA request will be handled as a request for a Type B meeting
D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of the same protocol
Answer: D
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