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Business, 19.10.2019 12:30 jnsoccerboy3121

When the sponsor-investigator holds the ind for an investigational drug he or she is responsible for annual reporting of which one of the following to fda?

a) adverse event summary report, but only from unblinded portions of studies ("open-label ind safety report")
b) marketing plan (i. e. annual updated projection of sales and profits)
c) ind report
d) ind renewal application

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