Exam (elaborations)
Reporting Serious Adverse Events in Investigations of Drugs and Biologics Quiz well Answered 2022
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The sponsor must submit an IND safety report to the FDA if an adverse event is (1) serious; (2) unexpected; AND: (3) there is a reasonable possibility that the drug caused the event. A double-blinded trial for a new indication is conducted under an IND comparing 2 marketed drugs, at twice the...
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