Which type of application do you need to file with the FDA to obtain approval to initiate clinical trials?

Which type of application do you need to file with the FDA to obtain approval to initiate clinical trials?

• A. IND (Investigational New Drug application)
• B. NDA (New Drug Application)
• C. BLA (Biologics License Application)
• D. PMA (Pre-market Approval)

Answer: (A)

Initiating human clinical trials requires FDA authorization known as an Investigational New Drug, or IND, application. This filing brings together preclinical safety data, manufacturing information, and the clinical trial protocol, and it grants permission to begin testing the product in humans, usually starting with Phase 1 studies under FDA oversight. The purpose is to ensure that early human testing is conducted with adequate safety measures while more data are gathered. Other pathways serve different purposes: a New Drug Application is submitted after trials to obtain approval to market a new drug; a Biologics License Application does the same for biologic products; and a Pre-market Approval is for medical devices, not drugs.

Initiating human clinical trials requires FDA authorization known as an Investigational New Drug, or IND, application. This filing brings together preclinical safety data, manufacturing information, and the clinical trial protocol, and it grants permission to begin testing the product in humans, usually starting with Phase 1 studies under FDA oversight. The purpose is to ensure that early human testing is conducted with adequate safety measures while more data are gathered. Other pathways serve different purposes: a New Drug Application is submitted after trials to obtain approval to market a new drug; a Biologics License Application does the same for biologic products; and a Pre-market Approval is for medical devices, not drugs.