quizlet the sponsor must submit an ind safety report to the fda if an adverse event is (1) serious; (2) unexpected; and:

1 answer:

4 0

The sponsor must submit an Ind safety report to the Food and Drug Administration if an adverse event is (1) serious; (2) unexpected; and (3) there is a reasonable possibility that the drug caused the event.

<h3>What is an IND safety report?</h3>

The safety reporting refers to any findings from tests in laboratory animals that suggest a significant risk for human subjects including reports of mutagenicity, teratogenicity and carcinogenicity.

Therefore, as a sponsor, you must submit an Ind safety report to the Food and Drug Administration if an adverse event is (1) serious; (2) unexpected; and (3) there is a reasonable possibility that the drug caused the event.

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