Which statement describes the regulatory purpose of the IND in the drug development process?

• A. It allows initial human testing by describing preclinical safety data and trial protocols
• B. It guarantees FDA approval
• C. It ensures market exclusivity
• D. It funds the trials

Answer: (A)

The IND is the mechanism that lets a sponsor begin initial testing in humans after submitting data that shows preclinical safety and a plan for how the clinical trials will be conducted. It gathers the animal pharmacology and toxicology results, chemistry and manufacturing information, and the proposed clinical trial protocol (including how the drug will be dosed, monitored, and evaluated). This review aims to ensure that risks to participants are minimized before people are exposed to a new drug. If the FDA deems the data and plan acceptable, testing in humans can start; it does not mean the drug is approved or that funding or market protection is granted.