In proposed studies using an active-control design

• The comparator drug to be used in the clinical study is considered an investigational new drug
• Sponsors must comply with FDA's IND regulations for both the comparator drug and the drug under investigation
• An FDA-approved drug without modification is most often used as the comparator
• Sponsors should identify the comparator drug, dosage form, strength, and manufacturer
• Include a statement that the drug is used without further modification