Under 21 CFR Part 312, what is the maximum duration of a Phase 1 clinical investigation that can be conducted under an IND before a Phase 2 protocol must be submitted?
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A
There is no specific time limit; Phase 1 can continue as long as needed
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B
6 months from IND effective date
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C
1 year from IND effective date
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D
Phase 2 protocol must be submitted before Phase 1 begins