Which statement about an Investigational New Drug application is correct?

• A. It is used to license a device
• B. It allows distribution across state lines before full FDA review
• C. It is the same as a New Drug Application
• D. It applies only to vaccines

Answer: (B)

An Investigational New Drug application is the pathway that authorizes starting human testing by letting the sponsor ship the investigational product across state lines and conduct clinical trials under FDA oversight before any marketing approval. This permission to move the product into humans and across state lines is the key role of an IND. It isn’t about licensing a device—devices follow a different regulatory route (Investigational Device Exemption). It isn’t the same as a New Drug Application, which is the later step to obtain marketing approval after trials. While vaccines can be studied under an IND as biologics, the IND concept applies more broadly to drugs and biologics, not just vaccines. Therefore, the statement about cross-state distribution prior to full FDA review best captures the purpose of an IND.