Which document is submitted to request FDA approval to begin human testing?

• A. New Drug Application (NDA)
• B. Investigational New Drug (IND)
• C. Phase 1 clinical trials
• D. Post-Marketing Surveillance

Answer: (B)

Beginning human testing for a new drug is allowed only after submitting an Investigational New Drug application to the FDA. This filing compiles preclinical data from laboratory and animal studies, plus the plan for initial human trials, including safety monitoring and how the first participants will be treated. Submitting and obtaining approval for the IND gives the go-ahead to start the first-in-human studies, ensuring there’sFDA oversight and a documented protocol for safety.

Once the IND is approved, researchers move into early human testing, known as Phase 1 trials, to evaluate safety, tolerability, and pharmacokinetics in a small group. After completing all trial phases and gathering sufficient safety and efficacy information, the sponsor submits a New Drug Application to seek marketing approval. Post-Marketing Surveillance is conducted after approval to monitor safety in the broader patient population.