[Answer] Which of the following would be true regarding a randomized trial comparing efficacy and toxicity of two FDA-approved medications for hypertension to support a change in advertising?

Answer: An IND would be required for the study. - IRB approval of a clinical investigation is required unless exempt under 21 CFR 56.104 or waived under 56.105. Route of administration dosage level or subject population are irrelevant for determining need for IRB approval. An IND is only required if the data will be used to support a new indication new labeling or change in advertising or if the research involves a route of administration dosage level or subject population that significantly increases the risks of the drug. This is true even if the drugs are FDA-approved.

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Which of the following would be true regarding a randomized trial comparing efficacy and toxic...

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