Before starting clinical research, which application must be submitted to the FDA?

• A. New Drug Application (NDA)
• B. Investigational New Drug (IND) application
• C. Summary of Pharmacovigilance Plan
• D. Certificate of Free Sale

Answer: (B)

Before any clinical testing in humans, the Investigational New Drug submission must be filed with the FDA. This filing allows the agency to review the drug’s preclinical safety data, the manufacturing information, and the proposed clinical trial protocol to ensure that the planned studies can be conducted safely. If the FDA does not place a hold, testing can proceed, typically after a 30-day review period.

The other documents relate to later stages or different purposes: the New Drug Application is used to obtain marketing approval after trials are completed; the Summary of Pharmacovigilance Plan describes safety monitoring but does not authorize starting human studies; and the Certificate of Free Sale shows that a product is legally marketed for export, not permission to begin clinical trials.