What is an Investigational Product (IP)?

What is an Investigational Product (IP)?

• A. Approved product used in standard care.
• B. Drug, device, or biologic under investigation.
• C. Only a device.
• D. Only a drug.

Answer: (B)

An Investigational Product is anything used or studied in a clinical trial that has not yet been approved for marketing in the country where the trial takes place. It can be a drug, a device, or a biologic, and it may include combination products or treatments being evaluated for safety and efficacy. That breadth is why describing an IP as a drug, device, or biologic under investigation best fits, because it covers all possible product types and emphasizes that the product is still under study rather than approved for standard care. An approved product used in standard care isn’t an IP, and limiting IP to only a device or only a drug misses the full range of possibilities.

An Investigational Product is anything used or studied in a clinical trial that has not yet been approved for marketing in the country where the trial takes place. It can be a drug, a device, or a biologic, and it may include combination products or treatments being evaluated for safety and efficacy. That breadth is why describing an IP as a drug, device, or biologic under investigation best fits, because it covers all possible product types and emphasizes that the product is still under study rather than approved for standard care. An approved product used in standard care isn’t an IP, and limiting IP to only a device or only a drug misses the full range of possibilities.