SOCRA CCRP Practice Exam

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How many days does a sponsor have to report withdrawal of FDA approval?

Immediately
Within 5 working days
Within 10 working days
Within 30 calendar days

The correct answer is: Within 5 working days

After FDA approval, the sponsor has 5 working days to report any withdrawal of approval. This is the most timely option compared to the other choices. While option A says "immediately," this is too vague and does not specify a specific timeframe. Option C and D mention "working days" and "calendar days" respectively, which can cause confusion as to the exact timeframe allowed for reporting. Therefore, option B is the best choice as it clearly states within 5 working days.