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?
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.

The trial would require an IND. - A clinical trial needs IRB approval unless it is exempt under 21 CFR 56.104 or is waived under 56.105. The method of administration, the dosage amount, or the patient population have no bearing on whether IRB approval is required. An IND is only necessary if the research involves an administration method, dosage level, or subject group that significantly raises the risks associated with the medicine, or if the findings would be used to support a new prescription, new labelling, or change in advertising. Even if the drugs have FDA approval, this is still true.

The United states Food And drug is in charge of protecting the public's health by maintaining the protection, efficacy, and security of pharmaceuticals for people and animals, biological products, & medical equipment, as well as the security of our nation's food supply, cosmetics, as well as radiation-emitting products.

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