What is the role of the IND in clinical development?

• A. It is the marketing authorization.
• B. It allows initiation of human clinical studies after regulatory review.
• C. It has no regulatory purpose.
• D. It is required only for Phase 3.

Answer: (B)

The IND is the regulatory permission to start testing a drug in humans. It ties together preclinical safety data, proposed clinical trial plans, details about how the drug will be manufactured, and information about the investigators. The regulatory agency reviews this information to ensure risks to participants are understood and controlled before any human exposure. If the IND is approved, you can begin human trials; if not, issues must be addressed before testing proceeds. This is not a marketing authorization—that comes later with a separate submission after successful clinical trials—and it applies to starting and conducting trials from the first-in-human phase through later phases, not just the last stage.